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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891657
Other study ID # GYN-08-002
Secondary ID
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


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
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