Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Leiomyoma Clinical Trial

Official title:

A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891657
• Other study ID #: GYN-08-002
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: September 4, 2014
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2014
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma
• Myoma

Intervention

Device:
• SprayShield™
Anti-adhesion barrier

Locations

Country	Name	City	State
Germany	Pius Clinic	Oldenburg

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Sites Adherent to the Uterus	The number of times an adhesion is attached to the uterus.	8-12 weeks post myomectomy	Yes
Primary	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.	8-12 weeks post myomectomy	Yes
Primary	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.	8-12 weeks post myomectomy	No
Primary	Area of Sites Adherent to the Uterus (cm^2)		8-12 weeks post myomectomy	No