Sepraspray™ Laparoscopic Myomectomy Study
A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
1 other identifier
interventional
41
1 country
3
Brief Summary
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2007
3 active sites
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, 2007
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 14, 2016
December 1, 2016
1.1 years
February 15, 2008
December 13, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
30 Days post surgery
Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.
Until end of study
Study Arms (2)
Sepraspray
EXPERIMENTALSepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm\^2.
Control
NO INTERVENTIONNo anti-adhesion treatment was used.
Interventions
Eligibility Criteria
You may qualify if:
- The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
You may not qualify if:
- Pregnant/lactating women.
- The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
- The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Naperville, Illinois, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
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
February 15, 2008
First Posted
February 27, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 14, 2016
Record last verified: 2016-12