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Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study)

NCT05058027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2021-09-27

No results posted yet for this study

Summary

This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery.

Conditions

  • Tissue Adhesion, Surgery-Induced

Interventions

DEVICE

GUARDIX-SG®

GUARDIX-SG® 6g prefilled syringe

DEVICE

Medicurtain®

Medicurtain® 5ml prefilled syringe

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Byung In Moon, MD, PhD · Ewha Womans University Mokdong Hospital

  • Hang-Seok Chang, MD, PhD · Gangnam Severance Hospital

  • Gil Soo Son, MD, PhD · Korea University

  • Seung Ki Kim, MD, PhD · Cha University Bundang Cha Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-04
Primary Completion
2014-08-28
Completion
2014-08-28

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 NCT05058027 on ClinicalTrials.gov