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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 is a NA study that has completed, run by BTL Industries. The registered enrollment target is 7 participants.
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.
Interventions
- DEVICE BTL-899
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-10-11 |
| Est. Completion | 2022-08-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05139745
The ClinicalTrials.gov registry entry for NCT05139745 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 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 BTL-899 is the first listed.
NCT05139745 reports 0 study locations.
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.
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