Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

This study is ongoing, but not recruiting participants.

First Received: April 30, 2009 No Changes Posted

Sponsored by:	Confluent Surgical
Information provided by:	Confluent Surgical
ClinicalTrials.gov Identifier:	NCT00891657

Purpose

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.

Condition	Intervention
Fibroid Myoma Leiomyoma	Device: SprayShield™

MedlinePlus related topics: Adhesions Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment
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

Further study details as provided by Confluent Surgical:

Primary Outcome Measures:

Adhesion formation. [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SprayShield™	Device: SprayShield™ Anti-adhesion barrier
2: No Intervention Control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891657

Locations

Germany
Pius Clinic
Oldenburg, Germany

Sponsors and Collaborators

Confluent Surgical

Investigators

Principal Investigator:

Rudy Leon De Wilde, MD

Pius Clinic

More Information

No publications provided

Responsible Party:	Confluent Surgical ( Vladimir I. Scerbin Jr., Senior Director, Clinical Affairs - Surgical Devices )
Study ID Numbers:	GYN-08-002
Study First Received:	April 30, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00891657 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Confluent Surgical:

Adhesion
Fibroid
Myoma
Leiomyoma
Myomectomy

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases

Adhesions
Myoma
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms
Myofibroma
Neoplasms by Histologic Type

Pathologic Processes
Connective Tissue Diseases
Adhesions
Neoplasms, Connective Tissue
Leiomyoma

ClinicalTrials.gov processed this record on May 07, 2009