Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Integra LifeSciences Corporation15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Fibroid Myoma Leiomyoma

Interventions

SprayShield™DEVICE

Anti-adhesion barrier

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pius Clinic

Oldenburg, Germany

Outcomes

Primary Outcomes

Number of Sites Adherent to the Uterus

The number of times an adhesion is attached to the uterus.

Time frame: 8-12 weeks post myomectomy

Mean Severity Score of Sites Adherent to the Uterus

The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.

Time frame: 8-12 weeks post myomectomy

Mean Extent Score of Sites Adherent to the Uterus

0 =no adhesions, 1=covering \<25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering \>51% of locations' total area.

Time frame: 8-12 weeks post myomectomy

Area of Sites Adherent to the Uterus (cm^2)

Time frame: 8-12 weeks post myomectomy

Data from ClinicalTrials.gov

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