Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 52 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03316950
The ClinicalTrials.gov registry entry for NCT03316950 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IntraGen RF is the first listed.
NCT03316950 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.