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NCT07661082 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain
A NA study, sponsored by BTL Industries.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT07661082 is a NA study that has completed, run by BTL Industries. The registered enrollment target is 24 participants.
The verdict
NCT07661082, a NA study, has completed, sponsored by BTL Industries.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
The study will evaluate the clinical efficacy and performance of the BTL-043 device for alleviating back pain. The study is a prospective, multi-center, open-label, single-arm study. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and the Quebec Back Pain Disability Index (QBPDS) will be administered. The subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatments, delivered 2-10 days apart. Therapy time is set to 30 minutes for each treatment. After the last treatment, the subjects will receive the ODI, QBPDS, and the Therapy Comfort Questionnaire to fill in along with the VAS. During the 1-month and 3-month follow-up visits, the subjects will fill in the Subject Satisfaction \& Quality of Life Questionnaire, in addition to the ODI, QBPDS, and VAS. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.
Interventions
- DEVICE Device: Treatment with BTL-043
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-08-09 |
| Est. Completion | 2025-03-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07661082
The ClinicalTrials.gov registry entry for NCT07661082 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 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 Device: Treatment with BTL-043 is the first listed.
NCT07661082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07661082 about?
NCT07661082 is a clinical study titled "Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain". The study will evaluate the clinical efficacy and performance of the BTL-043 device for alleviating back pain. The study is a prospective, multi-center, open-label, single-arm study. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits. All of the study subjec...
What is the current status of trial NCT07661082?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2024-08-09. Estimated completion is 2025-03-05.
What interventions are being tested in trial NCT07661082?
The interventions under investigation include: Device: Treatment with BTL-043 (DEVICE).
Who is sponsoring clinical trial NCT07661082?
This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.
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