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

Tissue Adhesion, Surgery-Induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058027
• Other study ID #: SPMC_0912
• Status: Completed
• Phase: N/A
• Start date: July 4, 2013
• Est. completion date: August 28, 2014

Study information

• Verified date: September 2021
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 28, 2014
• Est. primary completion date: August 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tissue Adhesion, Surgery-Induced
• Tissue Adhesions

Intervention

Device:
• GUARDIX-SG®
GUARDIX-SG® 6g prefilled syringe
• Medicurtain®
Medicurtain® 5ml prefilled syringe

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Gangnam-gu, Eonju-ro, 211

Sponsors (1)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 6
Secondary	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.	Follows up to week 6
Secondary	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.	Follows up to week 6