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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002845
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System 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

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Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
Study Start Date : October 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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



Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: intra-operative ]
    Ability to complete procedure without a need for conversion to a non-robotic approach

  2. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002845


Locations
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United States, Connecticut
Middlesex Hospital
Middletown, Connecticut, United States, 06457
United States, Michigan
St. Jose Mercey Health System
Ypsilanti, Michigan, United States, 48197
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Study Director: Shilpa Mehendale, MS Intutive Surgical
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT02002845    
Other Study ID Numbers: Non-Tumor based TORS procedure
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Intuitive Surgical:
Tongue base resection, partial glossectomy