Sepraspray™ Laparoscopic Myomectomy Study

Genzyme

Status: Completed

Conditions: Laparoscopic Myomectomy

Treatments: Device: Sepraspray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624390

SSPRAY00306

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Sepraspray

Experimental group

Description:

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.

Treatment:

Device: Sepraspray

Control

No Intervention group

Description:

No anti-adhesion treatment was used.