Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Not Applicable

Completed

• Conditions: Fibroid; Myoma; Leiomyoma
• Interventions: Device: SprayShield™

• Registration Number: NCT00891657
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Posted: 2009-05-01
• Results First Submitted: 2010-07-13
• Results First Submitted QC: 2010-08-10
• Results First Posted: 2010-08-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SprayShield™	SprayShield™	SprayShield™

Primary Outcome Measures

Name	Time	Method
Number of Sites Adherent to the Uterus	8-12 weeks post myomectomy	The number of times an adhesion is attached to the uterus.
Area of Sites Adherent to the Uterus (cm^2)	8-12 weeks post myomectomy
Mean Severity Score of Sites Adherent to the Uterus	8-12 weeks post myomectomy	The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Mean Extent Score of Sites Adherent to the Uterus	8-12 weeks post myomectomy	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.

Trial Locations

Locations (1)

Pius Clinic; 🇩🇪 Oldenburg, Germany