Thyroid NoduleNCT04320901
Energy Device Study in Transoral Endoscopic Thyroidectomy
A study testing Ligasure and Harmonic in people with Thyroid Nodule and Thyroid Cancer, run by Inha University Hospital at 1 site in South Korea.
Trial summary
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer
- What is being tested?
- Ligasure and Harmonic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 28 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who planned to transoral endoscopic thyroidectomy
- Age between 20 to 70
- Voluntarily consenting to the study and study agreement
- No local invasion or distant metastasis
- Normal vocal cord function in laryngoscopic exam
- No significant abnormalities in preoperative laboratory tests
Who cannot join
- Take aspirin or antiplatelet drugs within 7 days before admission
- Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Substance abuse and alcohol abuse
- History of esophageal and airway diseases
- Patient was participated in other clinical trials within 30 days
Show all 9Show fewer
- History of neck irradiation or surgery
- History of severe drug allergies
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, 22332
Jin Wook Yi, Dr., +82-32-890-3437, jinwook.yi@inha.ac.kr
About this study
Official title: Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
Read the detailed description
- This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.
- When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.
- According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.
- Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.
- Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.
- Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Being tested
- Ligasure, Harmonic
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigasureDevice
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
HarmonicDevice
Harmonic ACE 7+
| Study group | Role | What they receive |
|---|---|---|
| Harmonic | Experimental | Endoscopic procedure will be done by Harmonic ACE7+ Receives: Device: Harmonic |
| Ligasure | Experimental | Endoscopic procedure will be done by Ligasure Receives: Device: Ligasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Surgery time during the thyroid lobectomy
Measured: During the procedure
Camera cleaning frequency
Numbers of camera cleaning during the lobectomy
Measured: During the procedure
Blood loss
Estimated blood loss during the lobectomy
Measured: During the procedure
Secondary outcomes (2)
Pain score
visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)
Measured: Postoperative 1st and 2nd days
Drain amount
24-hour drain amount (ml/day)
Measured: Postoperative 1st and 2nd days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wook Yi, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320901
- Sponsor's protocol ID
- 2020-01-033
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park SY, Shin MH, Hwang YM, Choi YS, Yi JW. Comparative analysis between ultrasonic shears versus advanced bipolar device in transoral endoscopic thyroidectomy: a randomized controlled trial. Gland Surg. 2023 Sep 25;12(9):1191-1202. doi: 10.21037/gs-23-227. Epub 2023 Sep 18.
PubMed 37842523
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04320901
- Acronym / sponsor ID
- 2020-01-033
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 25 Mar 2020 (actual)
- 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.
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
Detailed description
- This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.
- When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.
- According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.
- Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.
- Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.
- Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic | Experimental | Device: HarmonicEndoscopic procedure will be done by Harmonic ACE7+ |
| Ligasure | Experimental | Device: LigasureEndoscopic procedure will be done by Ligasure |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who planned to transoral endoscopic thyroidectomy
- Age between 20 to 70
- Voluntarily consenting to the study and study agreement
- No local invasion or distant metastasis
- Normal vocal cord function in laryngoscopic exam
Key exclusion criteria (9 listed)
- Take aspirin or antiplatelet drugs within 7 days before admission
- Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Substance abuse and alcohol abuse
- History of esophageal and airway diseases
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 |
|---|---|---|
| LigasureLigasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm | Device | Ligasure |
| HarmonicHarmonic ACE 7+ | Device | Harmonic |
Primary outcome
Operation time
Time frame: During the procedure
Surgery time during the thyroid lobectomy
Camera cleaning frequency
Time frame: During the procedure
Numbers of camera cleaning during the lobectomy
Blood loss
Time frame: During the procedure
Estimated blood loss during the lobectomy
2 secondary outcomes
Pain score
Time frame: Postoperative 1st and 2nd days
Drain amount
Time frame: Postoperative 1st and 2nd days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 37842523Park SY, Shin MH, Hwang YM, Choi YS, Yi JW. Comparative analysis between ultrasonic shears versus advanced bipolar device in transoral endoscopic thyroidectomy: a randomized controlled trial. Gland Surg. 2023 Sep 25;12(9):1191-1202. doi: 10.21037/gs-23-227. Epub 2023 Sep 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligasure and Harmonic in people with Thyroid Nodule and Thyroid Cancer, run by Inha 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wook Yi, Professor (+82-32-890-3437, jinwook.yi@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320901, which also lists 1 linked publication.
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 21 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.