Status:
COMPLETED
The Efficacy and Safety of Thunderbeat in Thyroid Surgery
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Olympus Korea Co., Ltd.
Conditions:
Thyroid
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.
Detailed Description
Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter. In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same thermal conducti...
Eligibility Criteria
Inclusion
- thyroidectomy
- normal vocal cord
Exclusion
- additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
- Thyroid cancer patients with lymph node metastasis
- pregnant women
- uncontrolled hypertension, DM, chronic kidney failure, coagulation disorders
- aspirin or anti-platelet agent in 7 days
- Graves' disease or Hashimoto thyroiditis
- history of radiation treatment in head and neck area
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02304172
Start Date
November 1 2014
End Date
February 1 2016
Last Update
February 15 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744