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NCT02875561 · OUTCOME

Changes in Mental and Physical Wellness

Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia · Source last updated 2023-11-18

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (enrollment), End of Study (12 months)

What was measured

Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184

Analysis population: all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.

Groups in this outcome

Sonopet Ultrasonic Aspirator

Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation Sonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

CO2 Laser Ablation

Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation CO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

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

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator16
CO2 Laser Ablation25

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator16
CO2 Laser Ablation25
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sonopet Ultrasonic Aspirator155.629.8Not reportedNot reportedNot reported
CO2 Laser Ablation14529.1Not reportedNot reportedNot reported
End of Study

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator9
CO2 Laser Ablation11
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sonopet Ultrasonic Aspirator14726.4Not reportedNot reportedNot reported
CO2 Laser Ablation156.520.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.8
        value
        155.6
      2. group Id
        OG001
        spread
        29.1
        value
        145
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.4
        value
        147
      2. group Id
        OG001
        spread
        20.9
        value
        156.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    End of Study
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184
dispersion Type
Standard Deviation
groups
  1. description
    Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation Sonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
    id
    OG000
    title
    Sonopet Ultrasonic Aspirator
  2. description
    Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation CO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
    id
    OG001
    title
    CO2 Laser Ablation
param Type
MEAN
population Description
all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.
reporting Status
POSTED
time Frame
Baseline (enrollment), End of Study (12 months)
title
Changes in Mental and Physical Wellness
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice