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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

NCT00891657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-09-07

Study results available
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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.

Conditions

  • Fibroid
  • Myoma
  • Leiomyoma

Interventions

DEVICE

SprayShield™

Anti-adhesion barrier

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Rudy Leon De Wilde, MD · Pius Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00891657 on ClinicalTrials.gov