BEAM Procedure for Obesity

(BEAM Trial)

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Opioids, NSAIDs, others

Disqualifiers: Smoking, Pregnancy, Cardiopulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Day 0

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new weight loss procedure called Bariatric Endoscopic Antral Myotomy (BEAM) to assess its effects on weight loss and gut health in individuals with obesity. Researchers aim to determine if this procedure, performed without another common surgery, can aid in weight loss and affect stomach function and hormones. Participants will either receive the BEAM procedure along with lifestyle changes or continue with lifestyle changes alone. The trial seeks participants currently involved in a weight management program, with a BMI between 30 and 50, who are approved for certain weight loss procedures. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in weight loss treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that may interfere with weight loss or gastric emptying.

What prior data suggests that the BEAM procedure is safe for obesity treatment?

Research shows that the Bariatric Endoscopic Antral Myotomy (BEAM) procedure holds promise for safety. One study examined its feasibility and safety, finding that patients generally tolerated it well. Another study reported significant weight loss, with patients losing an average of 9.1% at 6 months and 12.2% at 12 months. Importantly, these outcomes occurred without major safety issues. The studies primarily focus on ensuring the procedure's safety and effectiveness for weight loss, and the safety results have been positive so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BEAM Procedure for obesity is unique because it combines an innovative technique called Bariatric Endoscopic Antral Myotomy (BEAM) with standard lifestyle modification therapy. Unlike traditional surgical options like gastric bypass or sleeve gastrectomy, BEAM is a less invasive endoscopic procedure that alters the stomach's function to help control hunger and promote weight loss. Researchers are excited about this approach because it could offer a safer, less invasive alternative to major surgery, potentially reducing recovery time and associated risks while still providing effective weight management.

What evidence suggests that the BEAM procedure is effective for obesity?

Research has shown that Bariatric Endoscopic Antral Myotomy (BEAM), which participants in this trial may receive, can aid weight loss in people with obesity. In an initial study, patients who underwent this procedure lost about 12% of their total body weight within a year. The procedure slows the stomach's emptying process, potentially helping individuals feel full longer and eat less. This method resembles adding a stomach muscle cut to another weight-loss procedure and has shown promise in earlier trials. While early results are encouraging, further research is needed to confirm its long-term effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with obesity (BMI of 30-50) who are mentally healthy and already in a weight loss program. They must be able to consent, attend follow-ups, and have had an endoscopy for bariatric evaluation. It's not for those with past GI surgery, drug interactions affecting gastric emptying, untreated infections or smoking habits, recent opioid use, pregnancy/lactation, severe heart/lung disease or other serious health issues.

Inclusion Criteria

I have had an endoscopy for weight loss surgery assessment.

Currently enrolled in the CWMW lifestyle modification program.

Available to return for all routine follow-up study visits

Exclusion Criteria

I have a serious health issue that makes endoscopy risky for me.

I have long-term stomach pain.

Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo Bariatric Endoscopic Antral Myotomy (BEAM) with standard of care lifestyle modification therapy

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for weight change, adverse events, and changes in pain scale, quality of life, gastric emptying, and metabolic profiles

12 months

Multiple visits at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Bariatric Endoscopic Antral Myotomy (BEAM)

Trial Overview

The study tests BEAM—a procedure that involves cutting muscles at the stomach exit to potentially aid in weight loss—on its own without sleeve gastroplasty. Participants will be randomly assigned to receive this treatment or not and will be monitored for weight loss effectiveness and changes in gastric function through breath tests and hormone levels.

How Is the Trial Designed?

Group I: BEAM Treatment Patients Experimental Treatment 1 Intervention

Subjects having esophagogastroduodenoscopy (EGD) with Bariatric Endoscopic Antral Myotomy (BEAM) with standard of care lifestyle modification therapy.

Group II: Lifestyle Modification Control Group Active Control 1 Intervention

Standard of care lifestyle modification therapy only.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05713071

Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) ...

Although early results suggest the addition of antral myotomy to ESG in the GEM procedure appears to increase weight loss and consistency of delayed gastric ...

2.

igiejournal.org

igiejournal.org/article/S2949-7086(23)00055-9/fulltext

Bariatric endoscopic antral myotomy: first-in-human proof ...

Gastroplasty with endoscopic myotomy (GEM) has been shown to consistently delay gastric emptying without triggering symptoms of gastroparesis and to produce ...

3.

trialx.com

trialx.com/clinical-trials/listings/219601/efficacy-and-safety-of-endoscopic-antral-myotomy-as-a-novel-weight-loss-procedure/

Efficacy and Safety of Endoscopic Antral Myotomy as a ...

Traditional bariatric surgery is very effective at treating obesity, however, only 1% of eligible patients elect to undergo this treatment ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38729312/

Bariatric endoscopic antral myotomy: a pilot study ...

At 6 and 12 months, patients achieved 9.1% ± 8.9% and 12.2% ± 7.1% total weight loss (P < .0005). The gastric-emptying rate was delayed by 36.6% in ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0016510724031869

Bariatric endoscopic antral myotomy: a pilot study ...

At 6 and 12 months, patients achieved 9.1% ± 8.9% and 12.2% ± 7.1% total weight loss (P < .0005). The gastric-emptying rate was delayed by 36.6% ...