Sepraspray™ Laparoscopic Myomectomy Study

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: February 15, 2008
Last updated: May 7, 2015
Last verified: May 2015

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.

Condition Intervention
Laparoscopic Myomectomy
Device: Sepraspray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. [ Time Frame: 30 Days post surgery ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sepraspray
Sepraspray 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.
Device: Sepraspray
No Intervention: Control
No anti-adhesion treatment was used.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.

Exclusion Criteria:

  • 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.
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Please refer to this study by its identifier: NCT00624390

United States, Illinois
Naperville, Illinois, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company ) Identifier: NCT00624390     History of Changes
Other Study ID Numbers: SSPRAY00306
Study First Received: February 15, 2008
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 13, 2015