Thyroid CancerNCT06573268
Da-vinci sp Versus xi Thyroid Surgery
An observational study of Thyroid Cancer and Thyroid Nodule, run by Inha University Hospital at 1 site in South Korea.
Trial summary
One year comparative analysis between SPRA* versus BABA** thyroid surgery. * SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery ** BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- What is being tested?
- robot surgery device
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2022to 1 Aug 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received robot thyroid surgery in our institution during study period
Who may be able to join
- Patients who received robot thyroid surgery in our institution
- Retrospective review
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-year Clinical Experiences of Single-port and Multi-port Robotic Thyroid Surgery in Single Institution
One year comparative analysis between SPRA* versus BABA** thyroid surgery. * SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery
** BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery
Read the detailed description
Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- robot surgery device
- Keywords
- thyroid, robotic surgical procedures, minimally invasive surgical procedures
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot surgery deviceDevice
SPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA)
| Study group | Role | What they receive |
|---|---|---|
| SPRA | patients who received da-Vinci SP robot thyroid surgery by SPRA method (Single Port Robotic Areolar) Receives: Device: robot surgery device | |
| BABA | patients who received da-Vinci SP robot thyroid surgery by BABA method (Bilateral Axillary Breast Approach) Receives: Device: robot surgery device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operation time (minutes)
Time for spending total surgery
Measured: on the surgery day (1 day)
Secondary outcomes (1)
Hospital stay days after surgery
Hospital admission days after surgery
Measured: after the surgery day (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Dec 2022
- Primary completion31 Dec 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 270 participants (actual)
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
- NCT06573268
- Sponsor's protocol ID
- 2024-08-015
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi YS, Choi JH, Jeon MS, Yu MJ, Lee HM, Shin AY, Yi JW. First Experience of Single-Port Robotic Areolar Approach Thyroidectomy. Clin Exp Otorhinolaryngol. 2023 Aug;16(3):275-281. doi: 10.21053/ceo.2023.00682. Epub 2023 Jul 5.
PubMed 37475141Choi YS, Shin WY, Yi JW. Single Surgeon Experience with 500 Cases of the Robotic Bilateral Axillary Breast Approach (BABA) for Thyroid Surgery Using the Da-Vinci Xi System. J Clin Med. 2021 Sep 7;10(18):4048. doi: 10.3390/jcm10184048.
PubMed 34575159
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Clinical Experiences of Single-port and Multi-port Robotic Thyroid Surgery in Single Institution
- ClinicalTrials.gov ID
- NCT06573268
- Acronym / sponsor ID
- 2024-08-015
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Keywords
- thyroid, robotic surgical procedures, minimally invasive surgical procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 Aug 2024 (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.
One year comparative analysis between SPRA* versus BABA** thyroid surgery. * SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery
** BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery
Detailed description
Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPRA | – | Device: robot surgery devicepatients who received da-Vinci SP robot thyroid surgery by SPRA method (Single Port Robotic Areolar) |
| BABA | – | Device: robot surgery devicepatients who received da-Vinci SP robot thyroid surgery by BABA method (Bilateral Axillary Breast Approach) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received robot thyroid surgery in our institution during study period
Key inclusion criteria (2 listed)
- Patients who received robot thyroid surgery in our institution
- Retrospective review
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| robot surgery deviceSPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA) | Device | BABA, SPRA |
Primary outcome
Total operation time (minutes)
Time frame: on the surgery day (1 day)
Time for spending total surgery
1 secondary outcome
Hospital stay days after surgery
Time frame: after the surgery day (up to 2 weeks)
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 27 Aug 2024.
- Results publication: PubMed 37475141Choi YS, Choi JH, Jeon MS, Yu MJ, Lee HM, Shin AY, Yi JW. First Experience of Single-Port Robotic Areolar Approach Thyroidectomy. Clin Exp Otorhinolaryngol. 2023 Aug;16(3):275-281. doi: 10.21053/ceo.2023.00682. Epub 2023 Jul 5.
- Results publication: PubMed 34575159Choi YS, Shin WY, Yi JW. Single Surgeon Experience with 500 Cases of the Robotic Bilateral Axillary Breast Approach (BABA) for Thyroid Surgery Using the Da-Vinci Xi System. J Clin Med. 2021 Sep 7;10(18):4048. doi: 10.3390/jcm10184048.
- Individual participant dataSharing planned: No
Related trials for Thyroid Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingPhase 2
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Metastic Thyroid Cancer
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Nodule, 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 2 inclusion and 1 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 27 Aug 2024. 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?
Total operation time (minutes) (time frame: on the surgery day (1 day)). 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 NCT06573268, which also lists 2 linked publications.
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 27 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.