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ObesityBAE2NCT04197336

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

A study testing Bariatric Embolization of Arteries with imaging visible Embolics in people with Obesity and Morbid Obesity, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Morbid Obesity, Weight Loss
What is being tested?
Bariatric Embolization of Arteries with imaging visible Embolics
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
10 Jan 2020to 14 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Pre-existing chronic abdominal pain
  • Positive stool occult blood study
  • GI bleeding or bleeding diathesis within 5 years
  • Weight loss (intentional or unintentional) of more than or equal to 5% of body weight in the 6 months prior to randomization
  • A weight loss greater than 6lb during the weight management run- in
  • Use of anti-obesity medications in the 12 months prior to screening
  • Endoscopic findings that would preclude bariatric embolization (at the discretion of the study team)
  • History of gastric motility disorders or an abnormal nuclear gastric motility examination (to be performed in diabetic subjects only)
  • American Society of Anesthesiologists Class 4 or 5 (very high risk surgical candidates: class 4=incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study - this exclusion criterion exists, because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects
  • Inflammatory bowel disease
  • Autoimmune disease or HIV+
  • History of allergy to iodinated contrast media
  • Failure to comply with pre-procedure weight management "run-in", or other pre-procedural visits (specifically, participants must complete 80% of weight management and Lose It! Food tracking, and 100% of one-time visits, i.e. MRI, computed tomography angiography (CTA), endoscopy)
  • Applicability of any contraindication regarding patient's vasculature as per Instruction for Use
  • Inability to have an MRI scan (i.e., metal implants or claustrophobia)
  • Smokers/vape users/tobacco use
  • Active or new-onset endocrine disorders (stable disease acceptable)
  • Other unforeseen conditions that may make patients unsuitable for the procedure (study team discretion)
  • As determined by clinical judgment based on Clinical Interview, psychological/behavioral measures, medical records, previous mental health records/other collateral information (as available) and consistent with diagnostic and statistical manual of mental disorders (DSM) -5 criteria:
  • Diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically significant mood disorders) AND/OR one or more of the following:
  • Evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, audio or visual hallucinations, paranoia, thought disturbance, severe impairment)
  • Evidence of minimal supports or limited adherence to ongoing mental health care
  • Failure to provide comprehensive aftercare plan that includes emergency plan for addressing future mental health relapse
  • History of treatment refractory mental illness/recurrent relapse (multiple suicide attempts or inpatient psychiatric hospitalizations in the past 5 years)
  • Within past 3 years: Inpatient psychiatric hospitalization
  • Within past 5 years: Suicide attempt
  • Declining to provide mental health records, a letter of support from mental health professionals, or consent for verbal consultation with mental health professionals when determined to be essential to evaluation.
  • Cognitive impairment, if judged to have
  • Limited capacity to make informed decision about procedure and inability to verbalize an understanding of the surgical procedure, risks and benefits.
  • Inability to demonstrate an understanding of the permanency of lifestyle change required
  • History of Anorexia or History of/Active Bulimia: If determined to be of low enough severity not to be a clear contraindication, minimum of 5 years abstinence from bulimia, current moderate to severe binge eating or night eating syndrome
  • Active or History of Substance Abuse with less than 5 years of abstinence
  • Current use of anti-tricyclic anti-depressants or steroids, psychiatric medications associated with weight gain.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Bariatric Embolization of Arteries With Imaging Visible Embolics

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.

Read the 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.

Being tested
Bariatric Embolization of Arteries with imaging visible Embolics
Medical subject headings
Obesity, Obesity, Morbid, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric Embolization of Arteries with imaging visible EmbolicsDevice

    Also called 100-200 µm radiopaque microspheres, Biocompatibles-001933

    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.

Study groups in NCT04197336
Study groupRoleWhat they receive
InterventionExperimentalThere 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.
Receives: Device: Bariatric Embolization of Arteries with imaging visible Embolics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. Change in Body Weight (Pounds)

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start10 Jan 2020
  3. Primary completion14 Dec 2023
  4. Study completion14 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot study
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197336
Sponsor's protocol ID
IRB00143169
Acronym
BAE2
Status last verified
Mar 2025
First submitted
11 Dec 2019
Last updated
17 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15728730

  • 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.

    PubMed 10875926

  • 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.

    PubMed 11473029

  • 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.

    PubMed 10604470

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric Embolization of Arteries with imaging visible Embolics in people with Obesity and Morbid Obesity, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight as Assessed by BMI (kg/m^2) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197336, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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