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The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)

NCT04638855 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

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, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.

Conditions

  • Intrauterine Synechiae
  • Tissue Adhesion, Surgery-Induced

Interventions

DEVICE

Medicurtain®

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

DEVICE

Placebo

No device after hysteroscopy surgery

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Byeongseok Lee, MD · Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South Korea

  • Youngsik Choi, MD · Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South Korea

  • Sun Hee Cha, MD · Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South Korea

  • Joomyung Kim, MD · CHEIL General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, South Korea

  • Ki-Hwan Lee, MD · Chungnam National University Hospital, 33 Munhwa-ro, Jung-gu, Daejeon, South Korea

  • In Taek Hwang, MD · Daejeon Eulji Medical Center, Dunsan-2-dong, Seo-gu, Daejeon, South Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-08
Primary Completion
2011-12-03
Completion
2011-12-03

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 NCT04638855 on ClinicalTrials.gov