NCT02517125Completed
Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 4 Aug 2015
- Start date
- Apr 2015
- Primary completion date
- Nov 2025
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Diseases
- Head and neck cancer
- NCT number
- NCT02517125
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From Apr 2015 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pathology against intercurrent-indicating cancer surgery
Other
- Metastasis (s) clinical or radiological remote, inaccessible (s) to a local curative treatment
- post-treatment tumor progression and / or early recurrence \< 3 months
- Unresectable tumor by robotic transorally: bone infiltration, deep infiltration of soft tissues, unresectable lymphadenopathy
- Contraindications to the suspension for transoral tumor Exposure: Dental fragility against-indication for cervical extension
- Pregnancy
- Inability to submit to medical monitoring study for geographical, social or psychological.
Who the study is looking for
- Patient \>/= 18
- WHO Status 0-2
- ENT cancer or solid tumor histologically proven regardless histology
- All maps of the head and neck and any stage
- surgically resectable according to clinical examination and preoperative investigations, confirmed in multidisciplinary meeting
- Treatment:
- First-line
- Or after induction chemotherapy
- Or local recurrence regardless of the previous treatment
- Or second location in irradiated
- Transoral exposition of tumor, assessed preoperatively during endoscopy during the balance of extension of the lesion
- The patient must have accepted the possibility of surgical conversion open surgery
- The patient must have been clearly informed of the study and have formulated his non-opposition to participate
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gustave Roussy Cancer Campus, Grand Paris Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.