- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891657
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
August 7, 2017 updated by: Integra LifeSciences Corporation
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oldenburg, Germany
- Pius Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females, 18 years of age or older, of child-bearing potential.
- Subject has at least one myoma >= 3 cm.
Exclusion Criteria:
- Pregnant or lactating females.
- Females undergoing prior open or closed myomectomy for treatment of myomas.
- Evidence of current active endometriosis or infection
- History of or active inflammatory bowel disease or pelvic inflammatory disease.
- Presence of a frozen pelvis, or hydrosalpinges.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SprayShield™
|
Anti-adhesion barrier
|
No Intervention: Control
No adhesion barrier administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
|
The number of times an adhesion is attached to the uterus.
|
8-12 weeks post myomectomy
|
Mean Severity Score of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
|
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
|
8-12 weeks post myomectomy
|
Mean Extent Score of Sites Adherent to the Uterus
Time Frame: 8-12 weeks post myomectomy
|
0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.
|
8-12 weeks post myomectomy
|
Area of Sites Adherent to the Uterus (cm^2)
Time Frame: 8-12 weeks post myomectomy
|
8-12 weeks post myomectomy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rudy Leon De Wilde, MD, Pius Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
April 30, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (Estimate)
May 1, 2009
Study Record Updates
Last Update Posted (Actual)
September 7, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GYN-08-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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