Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00891657
First received: April 30, 2009
Last updated: September 4, 2014
Last verified: September 2014
  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 Integra LifeSciences Corporation:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Pius Clinic
Oldenburg, Germany
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Principal Investigator: Rudy Leon De Wilde, MD Pius Clinic
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
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: September 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Integra LifeSciences Corporation:
Adhesion
Fibroid
Myoma
Leiomyoma
Myomectomy

Additional relevant MeSH terms:
Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014