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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepraspray | Experimental | 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. |
|
| Control | No Intervention | No anti-adhesion treatment was used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sepraspray | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naperville | Illinois | United States | ||||
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| Philadelphia |
| Pennsylvania |
| United States |
| Austin | Texas | United States |