Sepraspray™ Laparoscopic Myomectomy Study

Laparoscopic Myomectomy Clinical Trial

Official title:

A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624390
• Other study ID #: SSPRAY00306
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: December 13, 2016
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparoscopic Myomectomy

Intervention

Device:
• Sepraspray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.		30 Days post surgery	Yes
Primary	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	No