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NCT01083199 · OUTCOME

Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement

Global Performance Evaluation of the AMS CONTINUUM™ Device · Source last updated 2016-04-12

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

Measure
NUMBER
Unit
participants with device removal by 21d
Interval / dispersion
Not reported
Time frame
7-21 days post-Device placement

What was measured

Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)

Groups in this outcome

AMS CONTINUUM™ Device

Not reported

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

Analysis denominator · Participants

GroupSource count
AMS CONTINUUM™ Device10

Reported measurements

Source class 1
Values in participants with device removal by 21d · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AMS CONTINUUM™ Device10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)
groups
  1. id
    OG000
    title
    AMS CONTINUUM™ Device
param Type
NUMBER
reporting Status
POSTED
time Frame
7-21 days post-Device placement
title
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
type
PRIMARY
unit Of Measure
participants with device removal by 21d

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

Preserved source evidence · Not medical advice