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Robot-Assisted surgery shows promise for head and neck cancer

NCT ID NCT02517125

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a newer robotic surgery system (Da Vinci Xi) for removing head and neck tumors through the mouth. It included 100 adults with various types and stages of head and neck cancer. The main goal was to see if the procedure could be done successfully and safely. The approach aims to reduce the need for large incisions and speed up recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transoral robotic-assisted surgery with Da Vinci Xi (device)
What this could lead to
If successful, this could offer a less invasive surgical option for head and neck cancers, potentially reducing recovery time and side effects compared to open surgery.
What could go wrong
This is a small, early feasibility study (100 participants) with no control group. The device may not work for all tumor types or locations, and surgical risks like bleeding or infection remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Start date

Apr 2015

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient \>/= 18 2. WHO Status 0-2 3. ENT cancer or solid tumor histologically proven regardless histology 4. All maps of the head and neck and any stage 5. surgically resectable according to clinical examination and preoperative investigations, confirmed in multidisciplinary meeting 6. Treatment: * First-line * Or after induction chemotherapy * Or local recurrence regardless of the previous treatment * Or second location in irradiated 7. Transoral exposition of tumor, assessed preoperatively during endoscopy during the balance of extension of the lesion 8. The patient must have accepted the possibility of surgical conversion open surgery 9. The patient must have been clearly informed of the study and have formulated his non-opposition to participate Exclusion Criteria: 1. Metastasis (s) clinical or radiological remote, inaccessible (s) to a local curative treatment 2. post-treatment tumor progression and / or early recurrence \< 3 months 3. Unresectable tumor by robotic transorally: bone infiltration, deep infiltration of soft tissues, unresectable lymphadenopathy 4. Contraindications to the suspension for transoral tumor Exposure: Dental fragility against-indication for cervical extension 5. Pathology against intercurrent-indicating cancer surgery 6. Pregnancy 7. Inability to submit to medical monitoring study for geographical, social or psychological.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, Val de Marne, 94805, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.