Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00891657
First received: April 30, 2009
Last updated: November 6, 2013
Last verified: November 2013
  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™

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Number of Sites Adherent to the Uterus [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: Yes ]
    The number of times an adhesion is attached to the uterus.

  • Mean Severity Score of Sites Adherent to the Uterus [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: No ]
    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.

  • Area of Sites Adherent to the Uterus (cm^2) [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SprayShield™
SprayShield™
Device: SprayShield™
Anti-adhesion barrier
No Intervention: Control
No adhesion barrier administered.

  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: Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier: NCT00891657     History of Changes
Other Study ID Numbers: GYN-08-002
Study First Received: April 30, 2009
Results First Received: July 13, 2010
Last Updated: November 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Covidien:
Adhesion
Fibroid
Myoma
Leiomyoma
Myomectomy

Additional relevant MeSH terms:
Tissue Adhesions
Leiomyoma
Myofibroma
Myoma
Cicatrix
Fibrosis
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 22, 2014