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

Primary Purpose

Tissue Adhesion, Surgery-Induced

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GUARDIX-SG®

Medicurtain®

About this trial

This is an interventional prevention trial for Tissue Adhesion, Surgery-Induced focused on measuring Medicurtain®, Medicurtain, Anti-adhesion barrier, Sodium hyaluronate

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.)

Exclusion Criteria:

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

Sites / Locations

Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GUARDIX-SG®

Medicurtain®

Arm Description

Treat GUARDIX-SG 6g prefilled syringe after surgery

Treat Medicurtain® 5ml prefilled syringe after surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.

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

The questionnaire is composed of three questions as shown below. Discomfort around surgical area Discomfort when a patient bends his or her neck backward Inflammation reaction and scar formation around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.

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

The questionnaire is composed of four questions as shown below. Difficulty in swallowing the saliva Difficulty in swallowing the water Difficulty in swallowing the solid food Aesthetic self-satisfaction on the scar around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.

Full Information

NCT ID

NCT05058027

First Posted

September 10, 2021

Last Updated

September 16, 2021

Sponsor

Shin Poong Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05058027

Brief Title

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

Official Title

A Randomized, Multicenter, Subject and Assessor Blind, Parallel, Comparative Non-inferiority Clinical Trial Study to Assess the Anti-adhesive Effect and Safety of MEDICURTAIN® Applied to Undergoing Thyroid Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

July 4, 2013 (Actual)

Primary Completion Date

August 28, 2014 (Actual)

Study Completion Date

August 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shin Poong Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tissue Adhesion, Surgery-Induced

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GUARDIX-SG®

Arm Type

Active Comparator

Arm Description

Treat GUARDIX-SG 6g prefilled syringe after surgery

Arm Title

Medicurtain®

Arm Type

Experimental

Arm Description

Treat Medicurtain® 5ml prefilled syringe after surgery

Intervention Type

Device

Intervention Name(s)

GUARDIX-SG®

Other Intervention Name(s)

GUARDIX-SG

Intervention Description

GUARDIX-SG® 6g prefilled syringe

Intervention Type

Device

Intervention Name(s)

Medicurtain®

Other Intervention Name(s)

Medicurtain

Intervention Description

Medicurtain® 5ml prefilled syringe

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

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

Description

The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.

Time Frame

Week 6

Title

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

Description

Time Frame

Follows up to week 6

Title

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

Description

Time Frame

Follows up to week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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.) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byung In Moon, MD, PhD

Organizational Affiliation

Ewha Womans University Mokdong Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hang-Seok Chang, MD, PhD

Organizational Affiliation

Gangnam Severance Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gil Soo Son, MD, PhD

Organizational Affiliation

Korea University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seung Ki Kim, MD, PhD

Organizational Affiliation

Cha University Bundang Cha Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ewha Womans University Mokdong Hospital

City

Seoul

State/Province

Gangnam-gu, Eonju-ro, 211

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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