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

April 30, 2009
September 4, 2014
November 2008
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
Adhesion formation. [ Time Frame: 8-12 weeks post myomectomy ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00891657 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Fibroid
  • Myoma
  • Leiomyoma
Device: SprayShield™
Anti-adhesion barrier
  • Experimental: SprayShield™
    SprayShield™
    Intervention: Device: SprayShield™
  • No Intervention: Control
    No adhesion barrier administered.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00891657
GYN-08-002
No
Integra LifeSciences Corporation
Integra LifeSciences Corporation
Not Provided
Principal Investigator: Rudy Leon De Wilde, MD Pius Clinic
Integra LifeSciences Corporation
September 2014

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