Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000496415
Ethics application status
Approved
Date submitted
25/09/2007
Date registered
27/09/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic investigation of endometriosis using confocal endomicroscopy.
Scientific title
Women with symptoms of endometriosis who are indicated for diagnostic or therapeutic surgery undergo in vivo microscopic imaging of endometriosis lesions for comparison with conventional histopathological analysis of biopsied lesions to assess the diagnostic potential of endomicroscopy in identifying lesions prior to therapeutic intervention.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis. 2398 0
Condition category
Condition code
Reproductive Health and Childbirth 2510 2510 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Confocal endomicroscopy
In vivo microscopic imaging using an intravenously administered fluorescent contrast agent (Fluorescein Sodium 10%), is performed during the participant's therapeutic or diagnostic surgery. Depending upon the number of lesions identified, endomicroscopic imaging is expected to add 10-20 minutes to each participant's laparoscopic surgery (1 session per participant).
Intervention code [1] 2121 0
Diagnosis / Prognosis
Comparator / control treatment
Suspected endometriosis lesions will be biopsied at the time of laparoscopy, immediately prior to surgical intervention (e.g. ablation, excision) for conventional histopathological confirmation of the tissue type (endometriosis - uterine epithelium, endosalpingiosis - Fallopian tube epithelium, fibrosis, other normal tissue).
Control group
Active

Outcomes
Primary outcome [1] 3396 0
Endomicroscopy images from each lesion.
Timepoint [1] 3396 0
During laparoscopy approximately 20-30 images per lesion will be collected to document the surface and subsurface cellular structure.
Primary outcome [2] 3397 0
Macroscopic appearance of each lesion.
Timepoint [2] 3397 0
At laparoscopy, the macroscopic appearance of each lesion will be recorded and assessed immediately prior to collecting endomicroscopy images.
Primary outcome [3] 3398 0
Conventional histology from each lesion.
Timepoint [3] 3398 0
Histopathological analysis of each biopsied lesion will be available from pathology approximately 1 week post laparoscopy.
Secondary outcome [1] 5631 0
Accuracy of endomicroscopy for predicting histology based on a simple image classification system.
Timepoint [1] 5631 0
Predictions of histology will be made during laparoscopy immediately after images of each lesion are obtained and before the conventional histology results are known (accuracy of predictions will be measured in the second series of patients only, once data from the first 8 patients are analysed).

Eligibility
Key inclusion criteria
Women of reproductive age with symptoms consistent with endometriosis (including painful periods, pelvic pain, painful intercourse) who are indicated for diagnostic or therapeutic laparoscopy.
English speaking background.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women under the age of 18 years.
Patients with inadequate English.
Patients who are mentally or legally incapacitated or unable to give informed consent.
Allergy or prior adverse reaction to Fluorescein Sodium.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 269 0
3053
Recruitment postcode(s) [2] 270 0
3121

Funding & Sponsors
Funding source category [1] 2648 0
Commercial sector/Industry
Name [1] 2648 0
Optiscan Pty Ltd
Country [1] 2648 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Optiscan Pty Ltd
Address
15-17 Normanby Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 2397 0
None
Name [1] 2397 0
Address [1] 2397 0
Country [1] 2397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4567 0
Royal Women's Hospital Human Research & Ethics Committee
Ethics committee address [1] 4567 0
132 Grattan St
Carlton VIC 3053
Ethics committee country [1] 4567 0
Australia
Date submitted for ethics approval [1] 4567 0
Approval date [1] 4567 0
22/08/2007
Ethics approval number [1] 4567 0
07/19

Summary
Brief summary
The study aims to evaluate the diagnostic accuracy of a new cellular imaging device for identifying endometriosis lesions during surgery which require treatment or removal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28071 0
Address 28071 0
Country 28071 0
Phone 28071 0
Fax 28071 0
Email 28071 0
Contact person for public queries
Name 11228 0
Ms Elise Murr
Address 11228 0
15-17 Normanby Rd
Notting Hill VIC 3168
Country 11228 0
Australia
Phone 11228 0
+613 95383333
Fax 11228 0
+613 95627742
Email 11228 0
[email protected]
Contact person for scientific queries
Name 2156 0
Dr Martin Healey
Address 2156 0
Head of Unit
Gynaecology 2
The Royal Women's Hospital
132 Grattan St
Carlton VIC 3053
Country 2156 0
Australia
Phone 2156 0
+613 94259833
Fax 2156 0
+613 94278295
Email 2156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.