Patients With Thyroid CancerPhase 2EVATARNCT02839655
Prospective Study Assessing Thyroidectomy Using Robot
A Phase 2 study testing Da Vinci Xi in people with Patients With Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Thyroid Cancer
- What is being tested?
- Da Vinci Xi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2016to Aug 2022
- Phase
- Phase 2
- 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
Who may be able to join
- Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
- Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases <or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting
- Patient with no cons-indication to thyroid surgery or without dissection
- Patient general condition of WHO grade 0-1
- Patient age > 18 years and able to comply with the protocol visits
- Patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (Axillary or behind the ear channel)
- Patient Information or his legal representative and signed consent enlightened
- Patient affiliated to a system of social security or beneficiary of such a scheme
Who cannot join
- A history of cervical surgery or external beam radiation therapy
- Anomaly craniocervical hinge or symptomatic cervical spondylosis
- Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )
- paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )
- tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )
- metastatic cervical lymphadenopathy > 10 mm during the preoperative
- Pregnant women or during lactation
- patient already included in another clinical trial with a molecule experimental
Trial locations and contacts
1 site in 1 country.
About this study
The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.
Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.
- Conditions
- Patients With Thyroid Cancer
- Being tested
- Da Vinci Xi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci XiDevice
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci Xi | Experimental | Not described Receives: Device: Da Vinci Xi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy for benign tumor
If total thyroidectomy : rate of patients with thyroglobulin (Tg) under non- suppressive treatment with L-thyroxine ( LT4 ) <2 ng / ml to 3 months with a target value TSH between 0.5 and 2 ng / mL If lobectomy : size of the remaining thyroid ipsilateral to the surgery evaluated sonographically <11 mm ( larger diameter ) to 3 months
Measured: Assessed 3 months after surgery
Efficacy for malignant tumor
Rate of patients in complete remission at 12 months, remission defined as no biological or radiological anomaly:
- Tg / LT4 < 2 ng / ml in the absence of treatment with 131I ( in the absence of anti Tg antibodies) or Tg / LT4 <0.2 ng / mL in patients treated with 131I (absent anti Tg antibody )
- Normal cervical ultrasound
- Normal SPECT -CT if treatment with 131I
- If realized : CT and / or normal 18 FDG - PET
Measured: Assessed 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start30 Jun 2016
- Primary completion15 May 2018
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839655
- Sponsor's protocol ID
- 2015-A00989-40
- Other IDs
- 2015/2273
- Acronym
- EVATAR
- Status last verified
- Jun 2018
- First submitted
- 12 Jul 2016
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Assessing Thyroidectomy Using Robot
- ClinicalTrials.gov ID
- NCT02839655
- Acronym / sponsor ID
- EVATAR / 2015-A00989-40
- Conditions
- Patients With Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 21 Jul 2016 (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 robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.
Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Da Vinci Xi | Experimental | Device: Da Vinci Xi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
- Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases <or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting
- Patient with no cons-indication to thyroid surgery or without dissection
- Patient general condition of WHO grade 0-1
- Patient age > 18 years and able to comply with the protocol visits
Key exclusion criteria (8 listed)
- A history of cervical surgery or external beam radiation therapy
- Anomaly craniocervical hinge or symptomatic cervical spondylosis
- Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )
- paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )
- tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )
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 |
|---|---|---|
| Da Vinci Xi | Device | Da Vinci Xi |
Primary outcome
Efficacy for benign tumor
Time frame: Assessed 3 months after surgery
If total thyroidectomy : rate of patients with thyroglobulin (Tg) under non- suppressive treatment with L-thyroxine ( LT4 ) <2 ng / ml to 3 months with a target value TSH between 0.5 and 2 ng / mL If lobectomy : size of the remaining thyroid ipsilateral to the surgery evaluated sonographically <11 mm ( larger diameter ) to 3 months
Efficacy for malignant tumor
Time frame: Assessed 12 months after surgery
Rate of patients in complete remission at 12 months, remission defined as no biological or radiological anomaly: * Tg / LT4 < 2 ng / ml in the absence of treatment with 131I ( in the absence of anti Tg antibodies) or Tg / LT4 <0.2 ng / mL in patients treated with 131I (absent anti Tg antibody ) * Normal cervical ultrasound * Normal SPECT -CT if treatment with 131I * If realized : CT and / or normal 18 FDG - PET
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- 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. 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?
A Phase 2 study testing Da Vinci Xi in people with Patients With Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 8 inclusion and 8 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 15 Jun 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Efficacy for benign tumor (time frame: Assessed 3 months after surgery). The study lists 2 primary outcomes in all. 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 Jun 2018.