Meta description: A regulatory update on a trial testing two noninvasive devices to evaluate depressive symptoms urinary incontinence and sexual function in perimenopausal and postmenopausal women.
As of February 19, 2026 the sponsor BTL Industries Ltd lists recruiting status for EXOMIND BTL 699 2 and EMSELLA HPM 6000UF with active and sham arms as the two device interventions. For related reading see two posts: Device trial registry practices and Regulatory review of device claims.
The trial is registered on ClinicalTrials.gov under identifier NCT07413705 and the public record provides the conditions addressed including depressive symptoms urinary incontinence and sexual dysfunction.
What is the clinical trial design for the EXOMIND BTL 699 2 device and EMSELLA HPM 6000UF device?
The trial uses a parallel group design with two active device arms and two sham arms. Each device is tested against a sham control. Participants are perimenopausal or postmenopausal women with depressive symptoms urinary incontinence or sexual dysfunction. The sponsor is BTL Industries Ltd and the record indicates the trial is recruiting. The description is consistent with a regulatory analysis of device based interventions rather than a confirmation of efficacy.
Arms and comparators
Arms include EXOMIND active treatment and EXOMIND sham treatment as one pair, and EMSELLA active treatment and EMSELLA sham treatment as the second pair. Each device arm is evaluated independently against its sham counterpart in a parallel manner. The information provided does not include results or statistical plans.
Who is the target population?
The study focuses on women in the perimenopause and postmenopause stages who have depressive symptoms urinary incontinence or sexual dysfunction. The source text confirms recruitment and sponsor details but does not provide full eligibility criteria. The emphasis is on quality of life and device related safety in this population.
What interventions are tested and what devices are involved?
Two devices are involved EXOMIND produced by the sponsor and EMSELLA. EXOMIND is described as a BTL device and EMSELLA as a separate product. The trial tests active therapy for both devices in parallel with corresponding sham therapies. The sponsor positions these as two separate arms to assess device specific outcomes. The source text lists the conditions being studied as depressive symptoms urinary incontinence and sexual dysfunction.
What is the regulatory context and sponsor status?
The study is registered on ClinicalTrials.gov with identifier NCT07413705 and is described as recruiting. The sponsor is BTL Industries Ltd. Public registry entries support transparency about trial design and population and assist regulatory oversight for device evaluation. The information reflects early stage data generation rather than final labeling or marketing claims.
What are the next steps for participants and stakeholders?
If recruitment continues, data on depressive symptoms urinary incontinence and sexual function may be generated for the target population. Regulators will review any safety and performance information before considering updates to device labeling or expanded use. Clinicians patients and payers will await results to clarify potential benefits beyond sham treatment. The current status remains recruiting and no efficacy outcomes are provided in the source.
- What is the purpose of this trial? The trial aims to evaluate two noninvasive devices for depressive symptoms urinary incontinence and sexual function in women who are going through menopause.
- Who funds and sponsors the study? The sponsor is BTL Industries Ltd and the trial is listed as recruiting on ClinicalTrials.gov.
- Where can I find the registry entry? The official registry entry is on ClinicalTrials.gov with identifier NCT07413705.
In summary a regulatory minded evaluation is under way to assess EXOMIND and EMSELLA devices in a defined menopausal population. Stakeholders should monitor sponsor communications and the ClinicalTrials.gov listing for updates on recruitment and any data releases that may influence regulatory labeling decisions and clinical practice.
This information is for professional use and is not legal advice. It reflects statements from the source text and does not replace regulatory guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07413705?term=medical+device