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

NCT05058027 | Completed DMC

• 1 other identifier: SPMC_0912
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Medicurtain®; Medicurtain; Anti-adhesion barrier; Sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device.

  The percentage of abnormal findings measured as mild/moderate/severe in the esophageal motor performance score through marshmallow esophagography is the incidence of adhesion. The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.

  Week 6

Secondary Outcomes (3)

• Esophageal motility score assessed by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device

  Week 6

• Clinical Symptoms assessed using questionnaire by investigator assessed by using 10 point visual analogue scale (VAS).

  Follows up to week 6

• Clinical Symptoms assessed using questionnaire by subject assessed by using 10 point visual analogue scale (VAS).

  Follows up to week 6

Study Arms (2)

GUARDIX-SG®

ACTIVE COMPARATOR

Treat GUARDIX-SG 6g prefilled syringe after surgery

Device: GUARDIX-SG®

Medicurtain®

EXPERIMENTAL

Treat Medicurtain® 5ml prefilled syringe after surgery

Device: Medicurtain®

Interventions

GUARDIX-SG® DEVICE

GUARDIX-SG® 6g prefilled syringe

Also known as: GUARDIX-SG

GUARDIX-SG®

Medicurtain® DEVICE

Medicurtain® 5ml prefilled syringe

Also known as: Medicurtain

Medicurtain®

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject (male and female) aged between 20 \~ 65.
• The subject planned a first thyroidectomy for thyroid disease.
• The subject did not have medical history of esophagus-related disease
• The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)
• The subject who could communicate with the investigators fluently, understands the purpose of clinical trial and the risk of participation in the clinical trial, and was willing to comply with guideline for clinical trial.
• The subject has been informed of the nature of the study (objective, methodology, efficacy, etc.) and signed written informed consent.
• The subject has been informed the efficacy and risk of anesthesia related to the surgery, procedures and examination, etc. and singed written informed consent.
• The subject who agrees to comply with permitted contraception during the study (example of permitted contraception: using condom and infertility surgery, etc.)

You may not qualify if:

• The subject had general or local infection.
• The subject was diagnosed with liver and/or kidney and coagulation abnormalities.
• The subject took the prohibited concomitant medication.
• The subject had suppressed immunity or autoimmune disease
• The subject had hypersensitivity to the investigational devices.
• The subject was pregnant of a nursing mother or those who plan pregnancy during the study.
• The subject had serious disease that may affect to the study justified by Investigators (example: heart failure, kidney failure, pancreatitis, and diabetes, etc.)
• The subjects participate in another investigational study after enrollment of this study or subject previously participated in another investigational study within last 3 months before participating in this study.
• The subject considered to be not eligible to participate in the study justified by Investigator

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, Gangnam-gu, Eonju-ro, 211, South Korea

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Byung In Moon, MD, PhD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Hang-Seok Chang, MD, PhD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Gil Soo Son, MD, PhD

  Korea University

  PRINCIPAL INVESTIGATOR

• Seung Ki Kim, MD, PhD

  Cha University Bundang Cha Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 27, 2021
• Study Start: July 4, 2013
• Primary Completion: August 28, 2014
• Study Completion: August 28, 2014
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)