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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: Completed NA study, sponsored by BTL Industries.
NCT07661082 is a NA study that has completed, run by BTL Industries. The registered enrollment target is 24 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
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.
Primary Outcome
Oswestry Disability Index (ODI) The ODI will be used to evaluate the presence and impact of pain on the subjects' lives. The Oswestry Disability Index is a validated questionnaire used in assessment of back related pain and its impact on daily life. It consists of ten (10) items in total. The final score (sum of all items) is then calculated as a percentage of maximum possible points (50). The higher the percentage, the greater the disability.
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 |
What the finished NCT07661082 record still lists
NCT07661082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 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 Device: Treatment with BTL-043 is the first listed.
NCT07661082 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07661082's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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