Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

NCT04197336 | Completed Results DMC FDA Device

• 1 other identifier: IRB00143169
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight as Assessed by BMI (kg/m^2)

  Efficacy of Bariatric Embolization procedure assessed by change in body weight as assessed by BMI.

  12 months

• Change in Body Weight (Pounds)

  Efficacy of Bariatric Embolization procedure assessed by change in body weight (pounds)

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

There will be 10 pilot patients (See Statistical Analysis below for sample size calculations) for a total of 59 participants. Participants will be followed with study outcomes assessed for a period of 12 months. The duration of the study will be approximately three years.

Device: Bariatric Embolization of Arteries with imaging visible Embolics

Interventions

Bariatric Embolization of Arteries with imaging visible Embolics DEVICE

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.

Also known as: 100-200 µm radiopaque microspheres, Biocompatibles-001933

Intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥21 and ≤70 years
• Willing, able, and mentally competent to provide written informed consent
• Obese patients with a BMI ≥35 kg/m2
• Weight ≤400 lb
• 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
• Suitable for protocol therapy, as determined by the interventional radiology investigator
• Adequate hematologic (neutrophils\>1.5x109/L, platelets\>70x109/L, international normalized ratio (INR\<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)\>60milliliter mL/min. 1.73m2) function
• For females of reproductive potential: agreement to use of highly effective contraception
• for duration of study participation
• Patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise
• Live or work within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs

You may not qualify if:

• hemoglobin A1c greater than 8%
• Patients who are currently taking either Insulin or sulfonylurea (medication changes are allowed)
• Prior history of gastric, pancreatic, hepatic, and/or splenic surgery
• Prior radiation therapy to the upper abdomen
• Prior embolization to the stomach, spleen, or liver
• Cirrhosis
• Known portal venous hypertension
• Active peptic ulcer disease
• Significant risk factors for peptic ulcer disease, including daily NSAID use
• Large hiatal hernia, defined as \>5 cm in size
• Active H. Pylori infection
• Known aortic pathology, such as aneurysm or dissection
• Renal insufficiency, as evidenced by an estimated glomerular filtration rate of \<60 milliliter(mL)/min
• Major comorbidity, such as active cancer, significant cardiovascular disease, or peripheral arterial disease
• Pregnancy

Sponsors & Collaborators

• Johns Hopkins University: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• 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.

  PMID: 15728730 BACKGROUND

• 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.

  PMID: 10875926 BACKGROUND

• 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.

  PMID: 11473029 BACKGROUND

• 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.

  PMID: 10604470 RESULT

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Clifford Weiss, MD
• Organization: Johns Hopkins University

cweiss@jhmi.edu

410-614-1046

Study Officials

• Clifford Weiss, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants in the pilot will receive study intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: January 10, 2020
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)