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OpenTrials
Completed

NCT Number: NCT00891657

Post Market Study for an Adhesion Barrier Following 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.

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Key information

Conditions

Fibroid Cicatrix Fibrosis Leiomyoma Myoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pius Clinic

Oldenburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SprayShield™

Device

Anti-adhesion barrier

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 1, 2009
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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