Status:

COMPLETED

Sepraspray™ Laparoscopic Myomectomy Study

Lead Sponsor:

Genzyme, a Sanofi Company

Conditions:

Laparoscopic Myomectomy

Eligibility:

FEMALE

18-50 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

November 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00624390

Start Date

November 1 2007

End Date

December 1 2008

Last Update

December 14 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Naperville, Illinois, United States

2

Philadelphia, Pennsylvania, United States

3

Austin, Texas, United States