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Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy

NCT ID: NCT01696305

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).

An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.

During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.

Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.

Detailed Description

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Conditions

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Thyroid Disease

Keywords

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Thyroid disease Hyalobarrier Thyroidectomy anti-adhesive effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hyalobarrier

ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml\*10ml/syringe and 5cm-cannula

Group Type EXPERIMENTAL

Hyalobarrier

Intervention Type DEVICE

Guardix-SG

Poloxamer/sodium alginate mixture 6g/syringe

Group Type ACTIVE_COMPARATOR

Guardix-SG

Intervention Type DEVICE

Interventions

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Hyalobarrier

Intervention Type DEVICE

Guardix-SG

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female between 18 and 79 years of age
* Patients diagnosed with thyroid disease who will undergo total thyroidectomy
* Naive patients to thyroid surgery
* Given written informed consent
* Childbearing potential female patients who give the consent for contraception during the study

Exclusion Criteria

* Pregnant or breast-feeding female patients
* Abnormal coagulation panel test
* Clinically abnormal laboratory values
* Inappropriate general health conditions
* Past or current medication history for hyperthyroidism
* Medication with aspirin (or anti-platelet) before surgery
* Current medication with anticoagulants
* Inoperable (thyroidectomy) concurrent diseases
* Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes
* Participating in other interventional clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hoon Yub Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Jae-Bok Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Kyoung Sik Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Hyalobarrier_P3

Identifier Type: -

Identifier Source: org_study_id