Sepraspray™ Laparoscopic Myomectomy Study

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00624390
First received: February 15, 2008
Last updated: October 2, 2010
Last verified: October 2010
  Purpose

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 Genzyme, a Sanofi Company:

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: 1 Device: Sepraspray
No Intervention: 2

  Eligibility

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

Inclusion Criteria:

  • The patient must be a premenopausal women with myomsa 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624390

Locations
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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00624390     History of Changes
Other Study ID Numbers: SSPRAY00306
Study First Received: February 15, 2008
Last Updated: October 2, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014