NCT02304172

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

November 20, 2014

Last Update Submit

February 12, 2016

Conditions

Thyroid

Keywords

ThyroidectomyThunderbeat

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn

    postoperatively (from the day of surgery until 3 months postoperatively)

Secondary Outcomes (2)

  • Hemostasis

    intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)

  • Operative time

    from skin incision to skin closure

Study Arms (2)

Thunderbeat (Group A)

ACTIVE COMPARATOR

Patients submitted to thyroidectomy with the use of the Thunderbeat device.

Device: Thunderbeat (Group A)

Harmonic (Group B)

ACTIVE COMPARATOR

Patients submitted to thyroidectomy with the use of the Harmonic scalpel device

Device: Harmonic (Group B)

Interventions

Thunderbeat (Group A)DEVICE

hemostatic device utilized intraoperatively

Thunderbeat (Group A)
Harmonic (Group B)DEVICE

hemostatic device utilized intraoperatively

Harmonic (Group B)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • thyroidectomy
  • normal vocal cord

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Su-jin Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 1, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

KR(1)