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A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy

NCT02260115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-02-23

No results posted yet for this study

Summary

The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery. In addition, performance data following a clinical indicated second look laparoscopy will be collected for the purpose of determining sample size predictions for future trials.

Conditions

  • Tissue Adhesions

Interventions

DEVICE

LABS™

hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma

PROCEDURE

Surgical Control

Surgery only

Sponsors & Collaborators

  • Actamax Surgical Materials LLC

    lead INDUSTRY

Principal Investigators

  • Rudy DeWilde, MD, ScD, PhD · Professor and Head Department of Gynecology, Obstetrics and Gynecology Oncology, Pius-Hospital

  • Sara Y Brucker, MD, PhD · Deputy Head of Department of Gynecology and Obstetrics, University of Tubingen Women's Hospital

  • Matthias Korell, MD · Head Department of Obstetrics and Gynecology, Johanna Etienne-Krankenhaus

  • George A Pistofidis, MD · Director Department of Gynaecological Surgery Lefkos, Stavros Hospital

  • Geoffery H Trew, M.B.B.S · Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2016-07-31

Countries

  • Germany
  • Greece

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 NCT02260115 on ClinicalTrials.gov