- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058027
Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gangnam-gu, Eonju-ro, 211
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Seoul, Gangnam-gu, Eonju-ro, 211, Korea, Republic of
- Ewha Womans University Mokdong Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: GUARDIX-SG®
Treat GUARDIX-SG 6g prefilled syringe after surgery
|
GUARDIX-SG® 6g prefilled syringe
Other Names:
|
Experimental: Medicurtain®
Treat Medicurtain® 5ml prefilled syringe after surgery
|
Medicurtain® 5ml prefilled syringe
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Week 6
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Esophageal motility score assessed by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device
Time Frame: Week 6
|
The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
|
Week 6
|
Clinical Symptoms assessed using questionnaire by investigator assessed by using 10 point visual analogue scale (VAS).
Time Frame: Follows up to week 6
|
The questionnaire is composed of three questions as shown below.
|
Follows up to week 6
|
Clinical Symptoms assessed using questionnaire by subject assessed by using 10 point visual analogue scale (VAS).
Time Frame: Follows up to week 6
|
The questionnaire is composed of four questions as shown below.
|
Follows up to week 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPMC_0912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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