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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03909100




Registration number
NCT03909100
Ethics application status
Date submitted
18/03/2019
Date registered
9/04/2019

Titles & IDs
Public title
International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Scientific title
International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Secondary ID [1] 0 0
CMO-MA-PLS-0602
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-invasive Fat Reduction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CoolSculpting® System

Experimental: CoolSculpting® System - Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.


Treatment: Devices: CoolSculpting® System
A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall
Timepoint [1] 0 0
12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Secondary outcome [1] 0 0
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s)
Timepoint [1] 0 0
12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Secondary outcome [2] 0 0
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles
Timepoint [2] 0 0
12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Secondary outcome [3] 0 0
Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1
Timepoint [3] 0 0
12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Secondary outcome [4] 0 0
Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography
Timepoint [4] 0 0
Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [5] 0 0
First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)
Timepoint [6] 0 0
First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)

Eligibility
Key inclusion criteria
* Participant has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
* Participant has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
* Participant has a body mass index (BMI) of 18.5 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
* Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
* Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Minimum age
22 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Participant has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
* Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
* Participant needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
* Participant is pregnant or intending to become pregnant.
* Participant is lactating or has been lactating in the past 6-9 months.
* Participant is unable or unwilling to comply with study requirements.
* Participant is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participant has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
* Participant with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Participant with known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin such as cold urticaria or Raynaud's disease, or Chilblains (pernio).
* Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
* Participant with impaired peripheral circulation in the area to be treated
* Participant with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
* Participant with impaired skin sensation.
* Participant with open or infected wounds.
* Participant with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the participant's risk of bruising.
* Participant with recent surgery or scar tissue in the area to be treated.
* Participant has history of hernia in or adjacent to the treatment area(s) site.
* Participant with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
* Participant has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Participant is taking or has taken diet pills or supplements within the past 6 months.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the participant's response or the integrity of the data or would pose an unacceptable risk to the participant.
* Participant diagnosed with fibrosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2020
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Sandhurt Plastic Surgery - Bendigo
Recruitment hospital [2] 0 0
Academy Face and Body - Subiaco
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Middlesex
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Esther Jo
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03909100