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NCT03316950 · ClinicalTrials.gov registry record · NA
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT03316950: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT03316950 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03316950, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit, or DiVa HFL unit placebo. These treatments will be spaced one month apart and last about 25 minutes each. Each subject will be screened, undergo testing at baseline, and will be followed conservatively with no further therapy until they reach 6 months after the initiation of the designated treatment. At that time, all subjects will undergo subjective and objective testing. Those in the treatment group will be followed to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the placebo group will be provided a three-part treatment of the vulvovaginal area with the IntraGen RF unit and DiVA HFL unit. These treatments will be spaced one month apart and last about 25 minutes each. Six months after receiving three treatments of the dual therapy these patients will undergo subjective and objective testing. The primary outcome measure is improvement in vulvovaginal symptoms measured by the validated Vulvovaginal Symptoms Questionnaire. Data obtained from each investigation will be recorded in a password-protected digital spreadsheet, REDCap database and descriptive statistics will be obtained.
Primary Outcome
VSQ is a 21-item validated survey designed to assess postmenopausal quality-of-life parameters, namely vulvovaginal symptoms, emotions, life and sexual impact. Min: 0; Max: 21 Higher score would indicate greater number of symptoms.
Interventions
- DEVICE IntraGen RF
- DEVICE DiVA
- DEVICE Placebo (DIVA/IntraGen combined)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2021-04-08 |
| Phase | NA |
What the finished NCT03316950 record still lists
NCT03316950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which IntraGen RF is the first listed.
NCT03316950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03316950 about?
NCT03316950 is a clinical study titled "Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation". This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placeb...
What is the current status of trial NCT03316950?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2018-06-15. Estimated completion is 2021-04-08.
What interventions are being tested in trial NCT03316950?
The interventions under investigation include: IntraGen RF (DEVICE), DiVA (DEVICE), Placebo (DIVA/IntraGen combined) (DEVICE).
Who is sponsoring clinical trial NCT03316950?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03316950's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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