Sepraspray™ Laparoscopic Myomectomy Study

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00624390

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Laparoscopic Myomectomy	Device: Sepraspray	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sepraspray Sepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2.	Device: Sepraspray
No Intervention: Control No anti-adhesion treatment was used.

Arm

Intervention/Treatment

Experimental: Sepraspray

Sepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2.

Device: Sepraspray

No Intervention: Control

No anti-adhesion treatment was used.

Outcome Measures

Primary Outcome Measures

The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. [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. [Until end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Naperville	Illinois	United States
2	Philadelphia	Pennsylvania	United States
3	Austin	Texas	United States

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00624390

Other Study ID Numbers:

SSPRAY00306

First Posted:

Feb 27, 2008

Last Update Posted:

Dec 14, 2016

Last Verified:

Dec 1, 2016

Study Results

No Results Posted as of Dec 14, 2016