Study Summary
This trial found that transvascular bariatric embolization resulted in safe and effective weight loss in obese participants compared to control subjects.
Eligible Conditions
- Obesity
- Weight Loss
- Morbid Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 12 months
12 months
Efficacy of Bariatric Embolization procedure: Change in body weight
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Bariatric Embolization Procedure
1 of 2
Control Arm
1 of 2
Active Control
Non-Treatment Group
59 Total Participants · 2 Treatment Groups
Primary Treatment: Bariatric Embolization Procedure · Has Placebo Group · N/A
Control Arm
Other
ShamComparator Group · 1 Intervention: Control Arm · Intervention Types: OtherBariatric Embolization Procedure
Device
ActiveComparator Group · 1 Intervention: Bariatric Embolization of Arteries with imaging visible Embolics · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,569 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,166 Total Patients Enrolled
41 Trials studying Obesity
6,932 Patients Enrolled for Obesity
Clifford Weiss, M.D.Principal InvestigatorJohns Hopkins University
Eligibility Criteria
Age 21 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a male or female, aged ≥21 and ≤70 years.
You are willing, able, and mentally competent to provide written informed consent.
You are of reproductive potential.
You have participated in the study for at least 6 months.
You are living or working within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs.
Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography.
You have failed conservative weight loss therapy and are 18 or older.
Who else is applying?
What state do they live in?
| North Carolina | 14.3% |
| Virginia | 14.3% |
| Maryland | 14.3% |
| Other | 57.1% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Johns Hopkins University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 85.7% |
| Did not meet criteria | 14.3% |
Why did patients apply to this trial?
- "I've tried several dieting programs and they only work for a short time."
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Kojima, Masayasu, Hiroshi Hosoda, Yukari Date, Masamitsu Nakazato, Hisayuki Matsuo, and Kenji Kangawa. 1999. “Ghrelin Is a Growth-hormone-releasing Acylated Peptide from Stomach”. Nature. Springer Science and Business Media LLC. doi:10.1038/45230.
- Cummings, David E., Jonathan Q. Purnell, R. Scott Frayo, Karin Schmidova, Brent E. Wisse, and David S. Weigle. 2001. “A Preprandial Rise in Plasma Ghrelin Levels Suggests a Role in Meal Initiation in Humans”. Diabetes. American Diabetes Association. doi:10.2337/diabetes.50.8.1714.
- Loftus, Thomas M., Donna E. Jaworsky, Gojeb L. Frehywot, Craig A. Townsend, Gabriele V. Ronnett, M. Daniel Lane, and Francis P. Kuhajda. 2000. “Reduced Food Intake and Body Weight in Mice Treated with Fatty Acid Synthase Inhibitors”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.288.5475.2379.
- Hu, Zhiyuan, Seung Hun Cha, Goedelle van Haasteren, Jing Wang, and M. Daniel Lane. 2005. “Effect of Centrally Administered C75, a Fatty Acid Synthase Inhibitor, on Ghrelin Secretion and Its Downstream Effects”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.0500619102.
- Cummings DE, Purnell JQ, Frayo RS, Schmidova K, Wisse BE, Weigle DS. A preprandial rise in plasma ghrelin levels suggests a role in meal initiation in humans. Diabetes. 2001 Aug;50(8):1714-9. doi: 10.2337/diabetes.50.8.1714.
- Kojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K. Ghrelin is a growth-hormone-releasing acylated peptide from stomach. Nature. 1999 Dec 9;402(6762):656-60. doi: 10.1038/45230.
- Hu Z, Cha SH, van Haasteren G, Wang J, Lane MD. Effect of centrally administered C75, a fatty acid synthase inhibitor, on ghrelin secretion and its downstream effects. Proc Natl Acad Sci U S A. 2005 Mar 15;102(11):3972-7. doi: 10.1073/pnas.0500619102. Epub 2005 Feb 23.
- Loftus TM, Jaworsky DE, Frehywot GL, Townsend CA, Ronnett GV, Lane MD, Kuhajda FP. Reduced food intake and body weight in mice treated with fatty acid synthase inhibitors. Science. 2000 Jun 30;288(5475):2379-81. doi: 10.1126/science.288.5475.2379.
- 2020. "Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197336.
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