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

Completed

• Conditions: Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
• Interventions: Device: robotic surgery using the da Vinci Surgical System

• Registration Number: NCT02002845
• Lead Sponsor: Intuitive Surgical

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic arm	robotic surgery using the da Vinci Surgical System	Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System

Primary Outcome Measures

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

Trial Locations

Locations (3)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Middlesex Hospital; 🇺🇸 Middletown, Connecticut, United States

St. Jose Mercey Health System; 🇺🇸 Ypsilanti, Michigan, United States