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NCT05139745 · ClinicalTrials.gov registry record · NA
Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
A NA study, sponsored by BTL Industries.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05139745: Completed NA study, sponsored by BTL Industries.
NCT05139745 is a NA study that has completed, run by BTL Industries. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05139745, a NA study, has completed, sponsored by BTL Industries.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device. At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.
Primary Outcome
Biopsy samples of the abdominal fat tissue will be processed for histological evaluation by a certified laboratory. Conventional staining will be used to determine the changes in the fat tissue related to the increase in caspase-3 activity, which is associated with elevated levels of fat tissue apoptosis, and to examine other morphological changes of treated tissue, in all collected samples. Post-treatment findings will be compared to the baseline. The results of both study groups will be compar
Interventions
- DEVICE BTL-899
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-10-11 |
| Est. Completion | 2022-08-11 |
| Phase | NA |
What the finished NCT05139745 record still lists
NCT05139745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which BTL-899 is the first listed.
NCT05139745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05139745 about?
NCT05139745 is a clinical study titled "Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue". This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The sub...
What is the current status of trial NCT05139745?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2021-10-11. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT05139745?
The interventions under investigation include: BTL-899 (DEVICE).
Who is sponsoring clinical trial NCT05139745?
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 NCT05139745's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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