Sepraspray™ Laparoscopic Myomectomy Study

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.

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Key information

Conditions

Laparoscopic Myomectomy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Naperville, Illinois, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sepraspray

Device

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Feb 27, 2008
Registry last updated: Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed