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


Ages Eligible for Study:   18 Years and older
Genders 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
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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

No publications provided

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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Integra LifeSciences Corporation:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue processed this record on November 27, 2015