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NCT06846216 · ClinicalTrials.gov registry record · NA
Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness
A NA study, sponsored by BTL Industries.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT06846216: Completed NA study, sponsored by BTL Industries.
NCT06846216 is a NA study that has completed, run by BTL Industries. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06846216, a NA study, has completed, sponsored by BTL Industries.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the combined application of BTL-785F and HPM-6000UF Devices in improving quality of life in women with negative changes in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). The main question it aims to answer is: Does the combined application of BTL-785F and HPM-6000UF Devices reduces the score of the Vulvovaginal Symptoms Questionnaire? Participants will: * Undergo 6 treatment sessions.Three sessions will consist of combined application of BTL-785F and HPM-6000UF devices and three sessions will consist of standalone application of the HPM-6000UF device. * Attend follow-up visits * Complete questionnaires
Primary Outcome
The change in the score obtained from the Vulvovaginal Symptoms Questionnaire will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. The score ranges from 0 to 16 for sexually inactive women and from 0 to 20 for sexually active women. An improvement is defined as a decrease in score.
Interventions
- DEVICE Treatment with BTL-785F and HPM-6000UF Devices
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2024-04-05 |
| Phase | NA |
What the finished NCT06846216 record still lists
NCT06846216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment with BTL-785F and HPM-6000UF Devices is the first listed.
NCT06846216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06846216 about?
NCT06846216 is a clinical study titled "Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness". The goal of this clinical trial is to evaluate the combined application of BTL-785F and HPM-6000UF Devices in improving quality of life in women with negative changes in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). The main question it aims to an...
What is the current status of trial NCT06846216?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2023-02-20. Estimated completion is 2024-04-05.
What interventions are being tested in trial NCT06846216?
The interventions under investigation include: Treatment with BTL-785F and HPM-6000UF Devices (DEVICE).
Who is sponsoring clinical trial NCT06846216?
This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06846216's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 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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