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NCT00894933 · OUTCOME

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

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
7-21 days post-Device placement

What was measured

Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)

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 Device30

Reported measurements

Successful removal at 21 days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Continuum Device29Not reportedNot reportedNot reportedNot reported
Device not effective
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Continuum Device1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Successful removal at 21 days
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Device not effective
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
7-21 days post-Device placement
title
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice