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

NCT01696305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Thyroid Disease

Interventions

DEVICE

Hyalobarrier

DEVICE

Guardix-SG

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Hoon Yub Kim, M.D., Ph.D. · Korea University Anam Hospital

  • Jae-Bok Lee, M.D., Ph.D. · Korea University Guro Hospital

  • Kyoung Sik Park, M.D., Ph.D. · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696305 on ClinicalTrials.gov