Sepraspray™ Laparoscopic Myomectomy Study

Completed · Not applicable

Conditions studied: Laparoscopic Myomectomy

In brief

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.

Key facts

Study ID

NCT00624390

Run by

Genzyme, a Sanofi Company

People needed

41

Starts

2007-11-01

Expected to finish

2008-12-01

Last updated by the study team

2016-12-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Naperville, Illinois, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.