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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the BEAM treatment for obesity?

Research shows that endoscopic bariatric therapies, like the BEAM procedure, are emerging as effective treatments for obesity, offering a minimally invasive option that can lead to weight loss and improvement in related health issues like type 2 diabetes and high blood pressure. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new weight loss procedure called BEAM, which involves making a small cut in the stomach muscle. It aims to help people with obesity who haven't had success with other treatments. The procedure helps slow down food leaving the stomach, making people feel full longer and eat less.

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Available to return for all routine follow-up study visits

Currently enrolled in the CWMW lifestyle modification program.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoluminal weight loss and metabolic therapies: current and future techniques. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Natural orifice transluminal endoscopic one-anastomosis gastric bypass: a feasibility study using porcine model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Perception of Bariatric Surgery and Endoscopic Bariatric Therapies Among Primary Care Physicians. [2022]