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NCT04148651 · FLOW

Participant flow

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.

groups
  1. description
    All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen. The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
    id
    FG000
    title
    CO2RE® Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
        num Units
        12
      type
      STARTED
    2. achievements
      1. comment
        2 subjects did not complete the final follow-up due to COVID-19 pandemic
        group Id
        FG000
        num Subjects
        10
        num Units
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
        num Units
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Therefore, 12 subjects are included in this analysis.
type Units Analyzed
Treated areas
Complete source fields
groups
  1. description
    All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen. The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
    id
    FG000
    title
    CO2RE® Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
        num Units
        12
      type
      STARTED
    2. achievements
      1. comment
        2 subjects did not complete the final follow-up due to COVID-19 pandemic
        group Id
        FG000
        num Subjects
        10
        num Units
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
        num Units
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Therefore, 12 subjects are included in this analysis.
type Units Analyzed
Treated areas

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

Preserved source evidence · Not medical advice