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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014