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NCT00721539 · ADVERSE EVENTS

Adverse events

Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract · Source last updated 2016-11-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Six weeks from the surgical date for each subject
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Transoral Robotic Surgery

Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.

0 / 90 / 9Not reported / Not reported

Group identifiers: EG000: Transoral Robotic Surgery

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. description
        Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        9
        serious Num Affected
        0
        serious Num At Risk
        9
        title
        Transoral Robotic Surgery
      frequency Threshold
      0
      time Frame
      Six weeks from the surgical date for each subject

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice