A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

Intuitive Surgical

Status: Completed

Conditions: Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System

Treatments: Device: robotic surgery using the da Vinci Surgical System

Study type: Observational

Funder types: Industry

Identifiers

NCT02002845

Non-Tumor based TORS procedure

Details and patient eligibility

About

A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.

Full description

Primary Effectiveness Endpoint:

• Ability to complete procedure without a need for conversion to a non-robotic approach

Safety Endpoint:

Assessment of adverse events through post-operative follow-up including but not limited to:

• Bleeding

▪ Mortality

Additional endpoints evaluated may include:

• Procedure times
• Length of hospital stay
• Volume of tissue resected
• Use of tissue sealants

Enrollment: 285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
• Subject was ≥18 years of age at the time of procedure

Exclusion criteria

• Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
• Subject underwent a TORS procedure for oropharyngeal cancer

Trial design

285 participants in 1 patient group

Robotic arm

Description:

Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System

Treatment:

Device: robotic surgery using the da Vinci Surgical System