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NCT00656305 · OUTCOME

Number of Responders

ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain · Source last updated 2020-02-05

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
3 months post treatment

What was measured

Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.

Analysis population: 115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.

Groups in this outcome

ExAblate Treatment Arm

ExAblate 2000: MR guided focused ultrasound

ExAblate Sham Control Arm

ExAblate 2000: MR guided focused ultrasound sham

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

Analysis denominator · Participants

GroupSource count
ExAblate Treatment Arm81
ExAblate Sham Control Arm26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ExAblate Treatment Arm54Not reportedNot reportedNot reportedNot reported
ExAblate Sham Control Arm6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      26
    units
    Participants
description
Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.
groups
  1. description
    ExAblate 2000: MR guided focused ultrasound
    id
    OG000
    title
    ExAblate Treatment Arm
  2. description
    ExAblate 2000: MR guided focused ultrasound sham
    id
    OG001
    title
    ExAblate Sham Control Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.
reporting Status
POSTED
time Frame
3 months post treatment
title
Number of Responders
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice