Clinical trial NCT01696305: Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Official title: Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Disease
Keywords: Thyroid disease
Hyalobarrier
Thyroidectomy
anti-adhesive effect
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2012-10-01
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of normal esophageal transit in marshmallow esophagography
timeFrame: 6 Weeks after intervention
Secondary outcomes:
measure: Adhesion severity using VAS
timeFrame: Baseline and 1, 6 and 12 weeks
measure: Swallow impairment
timeFrame: Baseline and 1, 6 and 12 weeks
measure: Voice impairment
timeFrame: Baseline and 1, 6 and 12 weeks
measure: voice behavior using Voice Range Profile (VRP) assessment
timeFrame: Baseline and 1, 6 and 12 weeks
measure: Injury of recurrent laryngeal nerve
timeFrame: Baseline and 1, 6 and 12 weeks
measure: Postoperative Sore Throat within 24hours after thyroidectomy
timeFrame: Pre- and Post (0, 24h)-opreation
measure: Adverse Events
timeFrame: during 12 weeks after investigational device use
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Hoon Yub Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Jae-Bok Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Medical Center
name: Kyoung Sik Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: