ThyroidThunderbeatNCT02304172
The Efficacy and Safety of Thunderbeat in Thyroid Surgery
A study testing Thunderbeat (Group A) and Harmonic (Group B) in people with Thyroid, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid
- What is being tested?
- Thunderbeat (Group A) and Harmonic (Group B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- thyroidectomy
- normal vocal cord
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.
Read the 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 conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).
- Conditions
- Thyroid
- Being tested
- Thunderbeat (Group A), Harmonic (Group B)
- Keywords
- Thyroidectomy, Thunderbeat
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thunderbeat (Group A)Device
hemostatic device utilized intraoperatively
Harmonic (Group B)Device
hemostatic device utilized intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Thunderbeat (Group A) | Active comparator | Patients submitted to thyroidectomy with the use of the Thunderbeat device. Receives: Device: Thunderbeat (Group A) |
| Harmonic (Group B) | Active comparator | Patients submitted to thyroidectomy with the use of the Harmonic scalpel device Receives: Device: Harmonic (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Measured: postoperatively (from the day of surgery until 3 months postoperatively)
Secondary outcomes (2)
Hemostasis
Measured: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
Operative time
Measured: from skin incision to skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Korea Co., Ltd.
- Responsible party
- Principal investigator, Su-jin Kim, Seoul National University Hospital
- Investigators
- Su-jin Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304172
- Sponsor's protocol ID
- SNUHthyroid
- Acronym
- Thunderbeat
- Status last verified
- Feb 2016
- First submitted
- 20 Nov 2014
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02304172
- Acronym / sponsor ID
- Thunderbeat / SNUHthyroid
- Conditions
- Thyroid
- Keywords
- Thyroidectomy, Thunderbeat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Olympus Korea Co., Ltd.
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thunderbeat (Group A) | Active comparator | Device: Thunderbeat (Group A)Patients submitted to thyroidectomy with the use of the Thunderbeat device. |
| Harmonic (Group B) | Active comparator | Device: Harmonic (Group B)Patients submitted to thyroidectomy with the use of the Harmonic scalpel device |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- thyroidectomy
- normal vocal cord
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thunderbeat (Group A)hemostatic device utilized intraoperatively | Device | Thunderbeat (Group A) |
| Harmonic (Group B)hemostatic device utilized intraoperatively | Device | Harmonic (Group B) |
Primary outcome
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Time frame: postoperatively (from the day of surgery until 3 months postoperatively)
2 secondary outcomes
Hemostasis
Time frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively)
Operative time
Time frame: from skin incision to skin closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-jin Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thunderbeat (Group A) and Harmonic (Group B) in people with Thyroid, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn (time frame: postoperatively (from the day of surgery until 3 months postoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.