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

Overview

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 Title of Study: “A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 2014

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

Interventions

  • Device: robotic surgery using the da Vinci Surgical System

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intuitive Surgical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shilpa Mehendale, MS, Study Director, Intutive Surgical

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