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The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)

NCT04672421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-09-29

No results posted yet for this study

Summary

This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group. Adhesion formations at 8 weeks after the index surgery were compared between the two groups by using the well-defined grade scale and image recording.

Conditions

  • Laparoscopy
  • Tissue Adhesion, Surgery-Induced
  • Leiomyoma of the Uterine Body

Interventions

DEVICE

Medicurtain®

Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)

DEVICE

Placebo

No device after laparoscopic surgery

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Young-Tak Kim, MD, PhD · Asan Medical Center, Seoul Asan Medical Center Gil, Songpa-gu, Seoul, Korea

  • Tae Jin Kim, MD, PhD · Cheil General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, Korea

  • Yong-Il Kwon, MD, PhD · Kangdong Sacred Heart Hospital, (Gil 1dong445) 150, Seongnae-gil, Gwangsan-gu, Gwangju, Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-18
Primary Completion
2012-05-09
Completion
2012-05-09

Countries

  • South Korea

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 NCT04672421 on ClinicalTrials.gov