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Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.

Primary Purpose

Adhesion, Thyroid Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

HANBIO BarriGel

About this trial

This is an interventional prevention trial for Adhesion

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female between 20 and 70 years of age.
Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
Naïve patients to thyroid surgery.
Subjects are willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

Pregnant or lactating female patients.
Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse.
Patients with previous neck radiotherapy within 1 year.
Concurrent diseases/conditions which will be unable to evaluate the outcomes.
Patients receiving any adhesion prevention adjuvant.
Previous history of Keloid or hypertrophic scar.
Anticoagulant used within a week from surgery.
Subjects are hypersensitive to sodium hyaluronate.
Participate in another clinical trial within 1 month.
Patients presence of surgical site infection.
Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.

Sites / Locations

Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung Veterans General HospitalRecruiting
Keelung Chang Gung Memorial HospitalRecruiting
National Taiwan University HospitalRecruiting
Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

use HANBIO BarriGel

No anti-adhesive product

Arm Description

Outcomes

Primary Outcome Measures

Dysphagia Handicap Index (DHI)

Secondary Outcome Measures

Full Information

NCT ID

NCT05036525

First Posted

September 2, 2021

Last Updated

December 12, 2022

Sponsor

HAN Biomedical Inc

1. Study Identification

Unique Protocol Identification Number

NCT05036525

Brief Title

Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.

Official Title

Evaluation of the Efficacy and Safety of a High Molecular Weight Native Hyaluronic Acid Gel (HANBIO BarriGel) in Adhesion Prevention After Open Thyroidectomy: a Prospective, Randomized Controlled, Single Blind Study.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 17, 2022 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HAN Biomedical Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions

Detailed Description

The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.

6. Conditions and Keywords

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

Adhesion, Thyroid Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

use HANBIO BarriGel

Arm Type

Experimental

Arm Title

No anti-adhesive product

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

HANBIO BarriGel

Intervention Description

an anti-adhesive product

Primary Outcome Measure Information:

Title

Dysphagia Handicap Index (DHI)

Time Frame

Preoperative 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female between 20 and 70 years of age. Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection). Naïve patients to thyroid surgery. Subjects are willing to comply with all aspects of the study and have signed informed consent form. Exclusion Criteria: Pregnant or lactating female patients. Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse. Patients with previous neck radiotherapy within 1 year. Concurrent diseases/conditions which will be unable to evaluate the outcomes. Patients receiving any adhesion prevention adjuvant. Previous history of Keloid or hypertrophic scar. Anticoagulant used within a week from surgery. Subjects are hypersensitive to sodium hyaluronate. Participate in another clinical trial within 1 month. Patients presence of surgical site infection. Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen Lin Wu

Phone

886-2-26971328

hanbio008@hanbiomedical.com

Facility Information:

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi-Chia Chan, M.D.

Phone

+886-975-056-317

sparkle@cgmh.org.tw

First Name & Middle Initial & Last Name & Degree

Yi-Chun Lin

Phone

+886-989-841-950

lovestar0516@gmail.com

First Name & Middle Initial & Last Name & Degree

Yi-Chia Chan, M.D.

First Name & Middle Initial & Last Name & Degree

Shun-Yu Chi, M.D.

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tsung-Jung Liang, M.D.

tjliang@vghks.gov.tw

First Name & Middle Initial & Last Name & Degree

Hung-Ju Lu

Phone

+886-2-77200518

First Name & Middle Initial & Last Name & Degree

Tsung-Jung Tsung-Jung, M.D.

First Name & Middle Initial & Last Name & Degree

SHIUH-INN LIU, M.D.

Facility Name

Keelung Chang Gung Memorial Hospital

City

Keelung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Hsien Chen, M.D.

Phone

+886-975-366-177

Capitatecapitate@gmail.com

First Name & Middle Initial & Last Name & Degree

Yu-Hsien Chen, M.D.

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kuen-Yuan Chen, M.D.

Phone

+886-2-23123456

Ext

#72259

dtsurg51@gmail.com

First Name & Middle Initial & Last Name & Degree

Mon-Tzy Lu

Phone

+886-972872075

vul3196.lu@gmail.com

First Name & Middle Initial & Last Name & Degree

Kuen-Yuan Chen, M.D.

First Name & Middle Initial & Last Name & Degree

Ming-Hsun Wu, M.D.

Facility Name

Taipei Veterans General Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jui-Yu Chen, M.D.

Phone

+886-2-28757652

chenjy@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Ya-Jung Lu

Phone

+886-937492407

3337golden@gmail.com

First Name & Middle Initial & Last Name & Degree

Jui-Yu Chen, M.D.

First Name & Middle Initial & Last Name & Degree

Po-Chung Kuo, M.D.

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.

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