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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00737061
Registration number
NCT00737061
Ethics application status
Date submitted
14/08/2008
Date registered
18/08/2008
Date last updated
8/09/2017
Titles & IDs
Public title
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
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Scientific title
A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
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Secondary ID [1]
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P0071
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Universal Trial Number (UTN)
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Trial acronym
EASE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Reproductive Sterilization
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Adiana Transcervical Sterilization System
Experimental: Adiana Transcervical Sterilization System - Single arm treatment
Treatment: Devices: Adiana Transcervical Sterilization System
Implantation of silicone matrix in fallopian tubes
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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1 Year Pregnancy Rate
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Assessment method [1]
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Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Device Placement Rate
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Assessment method [1]
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Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
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Timepoint [1]
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After First Treatment Attempt
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Secondary outcome [2]
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Device Placement Rate
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Assessment method [2]
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Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
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Timepoint [2]
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Including Second Treatment Attempt
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Secondary outcome [3]
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Patient Satisfaction With Placement Procedure
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Assessment method [3]
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Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.
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Timepoint [3]
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48 hours
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Secondary outcome [4]
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Patient Satisfaction With Device Wearing
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Assessment method [4]
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Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
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Timepoint [4]
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Waiting Period (1-Month, 2-Months, 3-Months)
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Secondary outcome [5]
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Patient Satisfaction With Device Wearing
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Assessment method [5]
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Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
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Timepoint [5]
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Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
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Secondary outcome [6]
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Patient Comfort With Placement Procedure
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Assessment method [6]
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Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.
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Timepoint [6]
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Post-Procedure
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Secondary outcome [7]
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Patient Comfort With Placement Procedure
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Assessment method [7]
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Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.
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Timepoint [7]
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48 hours
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Secondary outcome [8]
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Patient Comfort With Device Wearing
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Assessment method [8]
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Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
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Timepoint [8]
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Waiting Period (1-Month, 2-Months, 3-Months)
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Secondary outcome [9]
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Patient Comfort With Device Wearing
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Assessment method [9]
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Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
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Timepoint [9]
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Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
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Secondary outcome [10]
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3 Year Pregnancy Rate
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Assessment method [10]
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Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.
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Timepoint [10]
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3 years
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Eligibility
Key inclusion criteria
- • Women aged 18 to 45
- Women who are seeking permanent contraception
- Women who are at risk of becoming pregnant
- Willing to risk becoming pregnant when relying on the Adiana device for
contraception
- Relatively normal uterine cavity, uterine wall thickness, and uterine size as
demonstrated by pelvic sonography
- Willing to keep a coital/menstrual log
- Have at least one confirmed pregnancy and one living child
- Monogamous relationship with a partner who has proven fertility
- Sexually active (at least 4 acts of intercourse per month)
- Willing to use alternate contraception (either a barrier method or oral
contraceptive pills or other monthly, cyclic, hormonal birth control) during the
three months following device placement prior to relying on the Adiana device for
contraception
- Willing and able to maintain in regular contact with the investigator
- Women with regular, cyclical menses within 2 months prior to the device placement
procedure
- Able to provide informed consent
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Women who are unsure of their desire to end their fertility
- Presence of gross genital infection, including sepsis
- Presence of chlamydia, gonorrhea or syphilis
- Presence of genital cancer (note: CIN1 is acceptable)
- Intra-uterine pathology which would prevent optimal access to the tubal ostium and
intramural portion of the fallopian tube, such as large submucous fibroids or uterine
adhesions
- History of chronic pelvic pain (present within the previous year), prior ectopic
pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea,
severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease
- Women with unresolved tubal, ovarian or endometrial pathology
- Uterine neoplasia or precursors to neoplasia
- Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three
months
- Women who have not had at least two normal periods after the following events:
irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal
birth control) which have since been discontinued, IUD removal, childbirth, or
termination of pregnancy
- Currently taking immunosuppressive medications including steroids
- Pregnancy
- Uterine perforation within the last 3 months
- Contraindications for surgical methods of sterilization
- Less than three months have passed since the last delivery or abortion
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/02/2013
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Sample size
Target
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Accrual to date
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Final
770
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Hospital for Women - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Connecticut
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United States of America
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State/province [4]
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Florida
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Country [5]
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State/province [5]
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Kansas
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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Minnesota
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State/province [8]
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Missouri
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Country [9]
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Tennessee
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United States of America
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State/province [11]
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Texas
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Country [12]
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United States of America
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State/province [12]
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Wisconsin
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Country [13]
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Mexico
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State/province [13]
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Nuevo Leon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hologic, Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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QST Consultations, Ltd.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical
Sterilization System for women who desire permanent birth control (female sterilization) by
occlusion of the fallopian tubes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00737061
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Edward Evantash, MD
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Address
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Hologic, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00737061
Download to PDF