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Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness

NCT06846216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-26

No results posted yet for this 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

Conditions

Interventions

DEVICE

Treatment with BTL-785F and HPM-6000UF Devices

Three treatment sessions will consist of the consecutive application of the BTL-785F and HPM-6000UF devices, delivered 5-10 days apart. Three sessions will consist of the standalone application of the HPM-6000UF device, delivered 2-4 days apart. The treatments with BTL-785 device equipped with BTL-785-3 applicator will last 2-10 minutes and with HPM-6000UF 28 minutes.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-04-05
Completion
2024-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846216 on ClinicalTrials.gov