Trial Outcomes & Findings for Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES) (NCT NCT04197336)

NCT ID: NCT04197336

Last Updated: 2025-03-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-03-17

Participant Flow

Ten pilot patients were enrolled. Due to funding, the study was stopped after 10 pilot patients.

Participant milestones

Measure	Bariatric Embolization Procedure 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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Bariatric Embolization Procedure 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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Baseline characteristics by cohort

Measure	Bariatric Embolization Procedure n=10 Participants 10 subjects will be enrolled in the bariatric embolization(BM) pilot arm. BM procedure will be performed under moderate sedation. Procedure will take 1.5 hr to 3 hr subject will be placed on the X-ray fluoroscopy table. Radial or femoral vascular access will be achieved using a small gauge needle, dilated over a guidewire to accommodate a 5 French vascular sheath. Standard catheters, 3 dimensional imaging will be acquired of the stomach, the arteries supplying the fundus arising off the celiac vessel. Microcatheter into the left gastric and/or gastroepiploic arteries supplying the fundus and small calibrated spheres will be infused until stasis of anterograde arterial flow is achieved, with particular care to avoid infusion of non-target arteries. The left gastric and/or gastroepiploic arteries will be embolized. Repeat 3 dimensional imaging: assess bead distribution and fundal coverage. Subject will be monitored in the recovery room and will be observed overnight.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Bariatric Embolization Procedure n=10 Participants 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.
Change in Body Weight as Assessed by BMI (kg/m^2)	43.7 kg/m^2 Standard Deviation 4.2

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Bariatric Embolization Procedure n=10 Participants 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.
Change in Body Weight (Pounds)	14.3 pounds Standard Deviation 22.5

Adverse Events

Pilot

Serious events: 3 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Measure	Pilot n=10 participants at risk Ten pilot participants will be used to test and refine the trial protocol, and data collection procedures.
Gastrointestinal disorders Ucler	10.0% 1/10 • Number of events 1 • Up to 1 year
General disorders Insomnia	10.0% 1/10 • Number of events 1 • Up to 1 year
Vascular disorders Site pseudoaneurysm	10.0% 1/10 • Number of events 1 • Up to 1 year

Other adverse events

Adverse event data not reported

Additional Information

Clifford Weiss, MD

Johns Hopkins University

Phone: 410-614-1046

Email: cweiss@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place