NCT04197336

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Bariatric Embolization of Arteries With Imaging Visible Embolics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Type	Name	Description
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.

Timeline

• Start date: 2020-01-10
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2019-12-13
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study