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Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)

NCT05049434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-09-20

No results posted yet for this study

Summary

This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus surgery, upon the aspects of adhesion prevention efficacy and safety.

Conditions

  • Sinusitis
  • Tissue Adhesion, Surgery-Induced

Interventions

DEVICE

Medicurtain®

Medicurtain® 5ml prefilled syringe

DEVICE

GUARDIX-SG®

GUARDIX-SG® 5ml prefilled syringe

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Heung-Man Lee, MD · Korea University, Guro Hospital 148 Gurodong-ro, Guro-gu, Seoul

  • Kyung-su Kim, MD · Gangnam Severance Hospital Yonsei University, 146-92 Dogok-dong, Gangnam-gu, Seoul

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-03
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT05049434 on ClinicalTrials.gov