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

NCT ID: NCT02002845

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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

Conditions

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

Keywords

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Tongue base resection, partial glossectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robotic arm

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

robotic surgery using the da Vinci Surgical System

Intervention Type DEVICE

Interventions

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robotic surgery using the da Vinci Surgical System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shilpa Mehendale, MS

Role: STUDY_DIRECTOR

Intutive Surgical

Locations

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Middlesex Hospital

Middletown, Connecticut, United States

Site Status

St. Jose Mercey Health System

Ypsilanti, Michigan, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Non-Tumor based TORS procedure

Identifier Type: -

Identifier Source: org_study_id