Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

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This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.

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Detailed Description

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Conditions

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Fibroid Myoma Leiomyoma

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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SprayShield™

Group Type EXPERIMENTAL

SprayShield™

Intervention Type DEVICE

Anti-adhesion barrier

Control

No adhesion barrier administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SprayShield™

Anti-adhesion barrier

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females, 18 years of age or older, of child-bearing potential.
* Subject has at least one myoma \>= 3 cm.

Exclusion Criteria

* Pregnant or lactating females.
* Females undergoing prior open or closed myomectomy for treatment of myomas.
* Evidence of current active endometriosis or infection
* History of or active inflammatory bowel disease or pelvic inflammatory disease.
* Presence of a frozen pelvis, or hydrosalpinges.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No