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

NCT ID: NCT05058027

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-04
• Study Completion Date: 2014-08-28

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.

Detailed Description

This clinical trial is a randomized, multi center, subject and evaluator blinded, parallel, comparative and non-inferiority clinical trial study to assess the prevention of adhesion formation in the subjects treated either MEDICURTAIN® or GUARDIX-SG at 6 weeks after total thyroidectomy.

The primary endpoint was defined as abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography. The objective of this study was to demonstrate the non-inferiority of investigational device versus control device for adhesion formation at 6 weeks after the administration of investigational or control devices.

Esophageal motility score and clinical symptoms assessed by the independent third evaluator using marshmallow esophagography at 6 weeks after administration of investigational device were secondary outcome.

Conditions

Tissue Adhesion, Surgery-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GUARDIX-SG®

Treat GUARDIX-SG 6g prefilled syringe after surgery

Group Type: ACTIVE_COMPARATOR

GUARDIX-SG®

Intervention Type: DEVICE

GUARDIX-SG® 6g prefilled syringe

Medicurtain®

Treat Medicurtain® 5ml prefilled syringe after surgery

Group Type: EXPERIMENTAL

Medicurtain®

Intervention Type: DEVICE

Medicurtain® 5ml prefilled syringe

Interventions

GUARDIX-SG®

GUARDIX-SG® 6g prefilled syringe

Intervention Type: DEVICE

Medicurtain®

Medicurtain® 5ml prefilled syringe

Intervention Type: DEVICE

Other Intervention Names

GUARDIX-SG; Medicurtain

Eligibility Criteria

Inclusion Criteria

1. The subject (male and female) aged between 20 ~ 65.

2. The subject planned a first thyroidectomy for thyroid disease.

3. The subject did not have medical history of esophagus-related disease

4. The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)

5. 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.

6. The subject has been informed of the nature of the study (objective, methodology, efficacy, etc.) and signed written informed consent.

7. The subject has been informed the efficacy and risk of anesthesia related to the surgery, procedures and examination, etc. and singed written informed consent.

8. The subject who agrees to comply with permitted contraception during the study (example of permitted contraception: using condom and infertility surgery, etc.)

Exclusion Criteria

1. The subject had general or local infection.

2. The subject was diagnosed with liver and/or kidney and coagulation abnormalities.

3. The subject took the prohibited concomitant medication.

4. The subject had suppressed immunity or autoimmune disease

5. The subject had hypersensitivity to the investigational devices.

6. The subject was pregnant of a nursing mother or those who plan pregnancy during the study.

7. The subject had serious disease that may affect to the study justified by Investigators (example: heart failure, kidney failure, pancreatitis, and diabetes, etc.)

8. 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.

9. The subject considered to be not eligible to participate in the study justified by Investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byung In Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Hang-Seok Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Gil Soo Son, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University

Seung Ki Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cha University Bundang Cha Hospital

Locations

Ewha Womans University Mokdong Hospital

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

Countries

South Korea

Other Identifiers

SPMC_0912

Identifier Type: -

Identifier Source: org_study_id