Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 31, 2010
CompletedSeptember 7, 2017
August 1, 2017
6 months
April 30, 2009
July 13, 2010
August 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Sites Adherent to the Uterus
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
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
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)
8-12 weeks post myomectomy
Study Arms (2)
SprayShield™
EXPERIMENTALSprayShield™
Control
NO INTERVENTIONNo adhesion barrier administered.
Interventions
Eligibility Criteria
You may qualify if:
- Females, 18 years of age or older, of child-bearing potential.
- Subject has at least one myoma \>= 3 cm.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pius Clinic
Oldenburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.
Results Point of Contact
- Title
- Director, Medical Affairs
- Organization
- Integra LifeSciences
Study Officials
- PRINCIPAL INVESTIGATOR
Rudy Leon De Wilde, MD
Pius Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 1, 2009
Study Start
November 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
September 7, 2017
Results First Posted
August 31, 2010
Record last verified: 2017-08