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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00891657
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : August 31, 2010
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Results First Submitted Date  ICMJE July 13, 2010
Results First Posted Date  ICMJE August 31, 2010
Last Update Posted Date September 7, 2017
Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Adhesion formation. [ Time Frame: 8-12 weeks post myomectomy ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
Official Title  ICMJE A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Fibroid
  • Myoma
  • Leiomyoma
Intervention  ICMJE Device: SprayShield™
Anti-adhesion barrier
Study Arms  ICMJE
  • Experimental: SprayShield™
    SprayShield™
    Intervention: Device: SprayShield™
  • No Intervention: Control
    No adhesion barrier administered.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891657
Other Study ID Numbers  ICMJE GYN-08-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Integra LifeSciences Corporation
Study Sponsor  ICMJE Integra LifeSciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rudy Leon De Wilde, MD Pius Clinic
PRS Account Integra LifeSciences Corporation
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP