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NCT07661121 · ClinicalTrials.gov registry record · NA
EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief
A NA study, sponsored by BTL Industries.
- Active
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT07661121 is a NA study that is active but no longer recruiting, run by BTL Industries. The registered enrollment target is 48 participants.
The verdict
NCT07661121, a NA study, is active but no longer recruiting, sponsored by BTL Industries.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits. During a single treatment session at each visit, subjects will receive consecutive treatment with both devices. At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed. A urine pregnancy test will be performed prior to each treatment visit. After the final treatment, subjects will complete the TCQ, SSQ \& QoL, TMD Disability Index, and VAS, and repeat all physical assessments. At both follow-up visits, subjects will complete the SSQ \& QoL, TMD Disability Index, and VAS, and repeat the physical assessments. Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.
Interventions
- DEVICE Treatment with BTL-043 and BTL-785F
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-12-08 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07661121
The ClinicalTrials.gov registry entry for NCT07661121 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BTL Industries, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treatment with BTL-043 and BTL-785F is the first listed.
NCT07661121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07661121 about?
NCT07661121 is a clinical study titled "EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief". This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up...
What is the current status of trial NCT07661121?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2025-12-08. Estimated completion is 2026-08.
What interventions are being tested in trial NCT07661121?
The interventions under investigation include: Treatment with BTL-043 and BTL-785F (DEVICE).
Who is sponsoring clinical trial NCT07661121?
This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.
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