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Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy


Phase 3
18 Years
79 Years
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The percentage of normal esophageal transit in marshmallow esophagography

Outcome Time Frame:

6 Weeks after intervention

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea University Anam Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

Hyalobarrier_P3

NCT ID:

NCT01696305

Start Date:

December 2012

Completion Date:

July 2013

Related Keywords:

  • Thyroid Cancer
  • Thyroid cancer
  • Hyalobarrier
  • Thyroidectomy
  • anti-adhesive effect
  • Thyroid Neoplasms
  • Thyroid Diseases

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