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Sepraspray™ Laparoscopic Myomectomy Study

NCT ID: NCT00624390

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Sepraspray

Intervention Type DEVICE

Control

No anti-adhesion treatment was used.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sepraspray

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Naperville, Illinois, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SSPRAY00306

Identifier Type: -

Identifier Source: org_study_id