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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

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

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™
Device: SprayShield™
Anti-adhesion barrier
No Intervention: Control
No adhesion barrier administered.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT00891657

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

Responsible Party: Integra LifeSciences Corporation 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

Keywords provided by Integra LifeSciences Corporation:

Additional relevant MeSH terms:
Tissue Adhesions
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Pathologic Processes
Neoplasms, Connective Tissue
Connective Tissue Diseases processed this record on August 16, 2017