Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)
NCT04197336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-03-17
Summary
The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.
Conditions
- Obesity
- Morbid Obesity
- Weight Loss
Interventions
- DEVICE
-
Bariatric Embolization of Arteries with imaging visible Embolics
bariatric embolization will be performed using tiny (100-200 μm), radiopaque (visible on X-ray) beads (referred to as BTG-001933) in order to suppress the body's signals for feeling hungry, which we predict will lead to weight loss.
Sponsors & Collaborators
-
Biocompatibles UK Ltd
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Clifford Weiss, M.D. · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-01-10
- Primary Completion
- 2023-12-14
- Completion
- 2023-12-14
- FDA Device
- Yes
Countries
- United States
Study Locations
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