Carpal Tunnel SurgeryCARTONCT06693258
Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study
A study testing thyroidectomy by robotic surgery via axillary approach and thyroidectomy by standard conventional surgery in people with Carpal Tunnel Surgery, run by Clinique Bizet at 1 site in France.
Trial summary
The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Surgery
- What is being tested?
- thyroidectomy by robotic surgery via axillary approach and thyroidectomy by standard conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject aged over 20 years
- Referred for a thyroidectomy (total or partial)
- Absence of participation in another clinical study
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Accepts the completion of the various study questionnaires
Who cannot join
- Patient under 20 years of age.
- Patients who have undergone combined radical cervical lymph node dissection
- Patient with a postoperative wound problem
- Patient with an underlying systemic disease that may influence the wound healing process
- Unable to undergo medical follow-up for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
clinique Bizet
Paris, 75116
bouchra benkessou, chef de projet, 07 64 48 60 16, b.benkessou@hexagone-sante-paris.fr
Patrick AIDAN, Doctor
About this study
Official title: A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy
The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)
- Conditions
- Carpal Tunnel Surgery
- Being tested
- thyroidectomy by robotic surgery via axillary approach, thyroidectomy by standard conventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomy by robotic surgery via axillary approachProcedure or surgery
thyroidectomy
thyroidectomy by standard conventional surgeryProcedure or surgery
thyroidectomy by standard conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | thyroidectomy by robotic surgery via axillary approach Receives: Procedure: thyroidectomy by robotic surgery via axillary approach |
| Control group | Active comparator | thyroidectomy by standard conventional surgery Receives: Procedure: thyroidectomy by standard conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the post-operative quality of life at D30 between the two groups
thyca-Qol
Measured: day 30
Secondary outcomes (3)
Total dysphagia score between the two groups
EAT-10 scale
Measured: Day7, Day30 and 3 months
Quality of the scar between the two groups
Vancouver scale
Measured: day 30
Assess the functional recovery of the vocal cords
fibroscopy
Measured: day 7 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start25 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SurgeryStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Comparative, Monocentric Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693258
- Sponsor's protocol ID
- 2024-A01697-40
- Acronym
- CARTO
- Status last verified
- Jan 2026
- First submitted
- 12 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy
- ClinicalTrials.gov ID
- NCT06693258
- Acronym / sponsor ID
- CARTO / 2024-A01697-40
- Conditions
- Carpal Tunnel Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 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.
The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Comparative, Monocentric Study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: thyroidectomy by robotic surgery via axillary approachthyroidectomy by robotic surgery via axillary approach |
| Control group | Active comparator | Procedure: thyroidectomy by standard conventional surgerythyroidectomy by standard conventional surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject aged over 20 years
- Referred for a thyroidectomy (total or partial)
- Absence of participation in another clinical study
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Accepts the completion of the various study questionnaires
Key exclusion criteria (5 listed)
- Patient under 20 years of age.
- Patients who have undergone combined radical cervical lymph node dissection
- Patient with a postoperative wound problem
- Patient with an underlying systemic disease that may influence the wound healing process
- Unable to undergo medical follow-up for the study.
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 |
|---|---|---|
| thyroidectomy by robotic surgery via axillary approachthyroidectomy | Procedure or surgery | Experimental group |
| thyroidectomy by standard conventional surgerythyroidectomy by standard conventional surgery | Procedure or surgery | Control group |
Primary outcome
Evaluate the post-operative quality of life at D30 between the two groups
Time frame: day 30
thyca-Qol
3 secondary outcomes
Total dysphagia score between the two groups
Time frame: Day7, Day30 and 3 months
Quality of the scar between the two groups
Time frame: day 30
Assess the functional recovery of the vocal cords
Time frame: day 7 and day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy by robotic surgery via axillary approach and thyroidectomy by standard conventional surgery in people with Carpal Tunnel Surgery, run by Clinique Bizet at 1 site in France.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the post-operative quality of life at D30 between the two groups (time frame: day 30). 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 10 Sep 2026.