Last reviewed · How we verify
NCT03545633
Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation
NA trial testing Treatment with High Intensity Focused ElectroMagnetic system. in Fat Burn. Withdrawn.
15 May 2019
Quick facts
| Lead sponsor | BTL Industries Ltd. |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 15 December 2017 |
| Primary completion | 15 May 2019 |
| Estimated completion | 15 June 2019 |
| Sites | 2 locations across United States, Bulgaria |
Drugs / interventions tested
- Treatment with High Intensity Focused ElectroMagnetic system.
Conditions studied
- Fat Burn — all drugs for Fat Burn →
Sponsor
BTL Industries Ltd. — full company profile →
Who can join
22 and older, any sex, with Fat Burn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits, 2 months, 6 and 12 months after the final treatment. At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the magnetic resonance imaging and the subject's weight will be recorded. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03545633
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other BTL Industries Ltd. trials
Trials by the same sponsor.
- NCT07413692 — BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and E · NA · recruiting
- NCT07413705 — BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and · NA · recruiting
- NCT07179224 — EEG Changes After rTMS Stimulation · NA · completed
- NCT07024550 — Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway · NA · active not recruiting
- NCT07027657 — EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03545633 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BTL Industries Ltd.
- Last refreshed: 14 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03545633.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing