TriangleNCT04148651 · OUTCOME
Treatment Associated Pain Score
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
- Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline
What was measured
Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.
Analysis population: A total of 57 sessions were conducted (10 subjects had 5 treatments,1 subject had 4 treatments and 1 subject had 3 treatments)
Groups in this outcome
CO2RE® Treatment
All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the 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).
| Group | Source count |
|---|---|
| CO2RE® Treatment | 12 |
| Group | Source count |
|---|---|
| CO2RE® Treatment | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CO2RE® Treatment | 2.6 | 2.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.5
- value
- 2.6
- denom Units Selected
- Number of Treatments
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- counts
- group Id
- OG000
- value
- 57
- units
- Number of Treatments
- description
- Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.
- dispersion Type
- Standard Deviation
- groups
- description
- All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the 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
- OG000
- title
- CO2RE® Treatment
- param Type
- MEAN
- population Description
- A total of 57 sessions were conducted (10 subjects had 5 treatments,1 subject had 4 treatments and 1 subject had 3 treatments)
- reporting Status
- POSTED
- time Frame
- Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline
- title
- Treatment Associated Pain Score
- type
- SECONDARY
- type Units Analyzed
- Number of Treatments
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice