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

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.

Study Overview

• Status: Completed
• Conditions: Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
• Intervention / Treatment: Device: robotic surgery using the da Vinci Surgical System

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Middlesex Hospital
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St. Jose Mercey Health System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic arm; Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System	Device: robotic surgery using the da Vinci Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	Ability to complete procedure without a need for conversion to a non-robotic approach	intra-operative
Primary Safety endpoint	Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality	up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Study Director: Shilpa Mehendale, MS, Intutive Surgical

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Tongue base resection, partial glossectomy
• Other Study ID Numbers: Non-Tumor based TORS procedure