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NCT04148651 · OUTCOME

Subject Satisfaction At the 12-Month Follow-up

The CO2RE® System for Vulvar Lichen Sclerosus · Source last updated 2022-03-22

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
12 months after the final treatment

What was measured

Evaluate Subject satisfaction at the 12 months post-last treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied\]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2) at the 12-month follow-up.

Analysis population: Two subjects missed the 12-month follow-up. Therefore, subject assessments were reported for 10 subjects at the 12-month follow-up.

Groups in this outcome

Subjects Treated With CO2RE® Treatment

All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.

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

Analysis denominator · Participants

GroupSource count
Subjects Treated With CO2RE® Treatment10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Subjects Treated With CO2RE® Treatment8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Evaluate Subject satisfaction at the 12 months post-last treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied\]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2) at the 12-month follow-up.
groups
  1. description
    All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
    id
    OG000
    title
    Subjects Treated With CO2RE® Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
Two subjects missed the 12-month follow-up. Therefore, subject assessments were reported for 10 subjects at the 12-month follow-up.
reporting Status
POSTED
time Frame
12 months after the final treatment
title
Subject Satisfaction At the 12-Month Follow-up
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice