Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Morbid Obesity
- Obesity
- Weight Loss
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: prospective, double-blinded, randomized, sham-controlled studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: All procedure images and reports, regardless of the randomization arm, will be kept with the unblinded member of the study team, and will not be housed centrally. All participants will adhere to the same follow-up schedule, meeting with blinded members of the study team only. The procedural team will not have further contact with the participant, the participant will only be followed by the blinded study team. Once the study is closed, all reports and images will be entered into the clinical record.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 70 years
- Gender
- Both males and females
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 obesi...
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.
Tracking Information
- NCT #
- NCT04197336
- Collaborators
- Biocompatibles UK Ltd
- Investigators
- Principal Investigator: Clifford Weiss, M.D. Johns Hopkins University