NCT02517125

Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Transoral robotic-assisted surgery with Da Vinci Xi

Timeline

• Start date: 2015-04-01
• Primary completion: 2025-11-01
• Completion: 2025-11-04
• First posted: 2015-08-06
• Last updated: 2026-03-30

Locations

1 site across 1 country: France