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OpenTrials
Completed

NCT Number: NCT02002845

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Middlesex Hospital, Middletown, Connecticut, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robotic surgery using the da Vinci Surgical System

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.