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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

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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

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.

Condition or disease Intervention/treatment Phase
Fibroid Myoma Leiomyoma Device: SprayShield™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SprayShield™
SprayShield™
Device: SprayShield™
Anti-adhesion barrier

No Intervention: Control
No adhesion barrier administered.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Area of Sites Adherent to the Uterus (cm^2) [ Time Frame: 8-12 weeks post myomectomy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891657


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

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00891657     History of Changes
Other Study ID Numbers: GYN-08-002
First Posted: May 1, 2009    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: September 7, 2017
Last Verified: August 2017

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

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