NCT01696305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

September 26, 2012

Last Update Submit

February 27, 2014

Conditions

Thyroid Disease

Keywords

Thyroid diseaseHyalobarrierThyroidectomyanti-adhesive effect

Outcome Measures

Primary Outcomes (1)

  • The percentage of normal esophageal transit in marshmallow esophagography

    6 Weeks after intervention

Secondary Outcomes (7)

  • Adhesion severity using VAS

    Baseline and 1, 6 and 12 weeks

  • Swallow impairment

    Baseline and 1, 6 and 12 weeks

  • Voice impairment

    Baseline and 1, 6 and 12 weeks

  • voice behavior using Voice Range Profile (VRP) assessment

    Baseline and 1, 6 and 12 weeks

  • Injury of recurrent laryngeal nerve

    Baseline and 1, 6 and 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Hyalobarrier

EXPERIMENTAL

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

Device: Hyalobarrier

Guardix-SG

ACTIVE COMPARATOR

Poloxamer/sodium alginate mixture 6g/syringe

Device: Guardix-SG

Interventions

HyalobarrierDEVICE
Hyalobarrier
Guardix-SGDEVICE
Guardix-SG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Konkuk University Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Hoon Yub Kim, M.D., Ph.D.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Jae-Bok Lee, M.D., Ph.D.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • Kyoung Sik Park, M.D., Ph.D.

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 1, 2012

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

KR(3)