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NCT00894933 · OUTCOME

Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention

Performance Evaluation of the AMS CONTINUUM™ Device · Source last updated 2018-02-22

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

Measure
NUMBER
Unit
Events
Interval / dispersion
Not reported
Time frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

What was measured

Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

Analysis population: Subjects in whom device placement was attempted

Groups in this outcome

Continuum Device

Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Continuum Device31

Reported measurements

Source class 1
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Continuum Device0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
groups
  1. description
    Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
    id
    OG000
    title
    Continuum Device
param Type
NUMBER
population Description
Subjects in whom device placement was attempted
reporting Status
POSTED
time Frame
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
title
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
type
PRIMARY
unit Of Measure
Events

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

Preserved source evidence · Not medical advice