What is the mechanism of action of this treatment?

Common treatments for obesity, such as Bariatric Endoscopic Antral Myotomy (BEAM), work by modifying the stomach's anatomy to influence gastric emptying and hormone levels. BEAM involves antral myotomy, which can accelerate gastric emptying and alter the release of gut hormones like ghrelin, which regulates appetite. These changes help reduce hunger and improve satiety, leading to significant weight loss. This is crucial for obesity patients as it not only aids in weight reduction but also improves metabolic health, potentially resolving comorbid conditions like type 2 diabetes and hypertension.

What side effects are associated with this type of intervention?

Common treatments for obesity similar to BEAM include gastric balloon therapy and various forms of endoscopic myotomy. Known side effects of these treatments can include nausea, vomiting, abdominal pain, and potential complications related to the endoscopic procedure itself, such as infection or perforation. Additionally, there may be changes in gut hormone levels, which can affect appetite and digestion. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that involve modifications to the stomach or influence gut hormones. These include bariatric surgeries like gastric bypass and sleeve gastrectomy, which physically alter the stomach to reduce its size and modify gut hormone levels to promote weight loss. Additionally, endoscopic procedures such as the intragastric balloon and endoscopic sleeve gastroplasty have been approved, which also aim to reduce stomach volume and affect gastric emptying. Pharmacological treatments that influence gut hormones, such as GLP-1 receptor agonists (e.g., liraglutide), have also been approved for obesity management. These treatments share similarities with BEAM in their approach to modifying gastric physiology and hormone levels to achieve weight loss.

What other types of research exist?

Promising alternatives to BEAM for obesity treatment include: 1) Endoscopic Sleeve Gastroplasty (ESG), which reduces stomach volume using sutures; 2) Intragastric Balloon (IGB) therapy, where balloons are placed in the stomach to reduce food intake; 3) Duodenal-Jejunal Bypass Liner (DJBL), a device that mimics the effects of gastric bypass surgery; and 4) Gastric Peroral Endoscopic Myotomy (G-POEM), which targets the pylorus to improve gastric emptying. These alternatives have shown efficacy in weight loss and metabolic improvements in recent studies.

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Procedure

BEAM Procedure for Obesity (BEAM Trial)

N/A

Waitlist Available

Led By Christopher C. Thompson, MD, MSc

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnostic endoscopy approved for bariatric evaluation

Subjects must be 18-70 years of age

Must not have

Any serious health condition unrelated to their weight that would increase the risk of endoscopy

Chronic abdominal pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, 1 month, 3 month, 6 month, 9 month, 12 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may cause sore throat from the endoscope tube insertion during the procedure; abdominal pain; nausea; potential risks include bleeding or infection at the site of myotomy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had an endoscopy for weight loss surgery assessment.

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I am between 18 and 70 years old.

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I am a candidate for weight loss surgery or procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have long-term stomach pain.

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I have an untreated thyroid condition affecting my weight.

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I have a serious stomach condition, like cancer or a precancerous disease.

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I do not have severe heart or lung disease, recent heart attacks, uncontrolled high blood pressure, or a need for NSAIDs.

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I am not taking medication that affects how my stomach empties.

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I have had surgery on my digestive system.

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I have an untreated H. pylori infection.

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I have been treated with opioids in the past year.

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I have had surgery on the opening of my stomach.

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I have a blockage in my digestive tract.

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I have varices in my esophagus or stomach, or gastropathy due to portal hypertension.

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I do not have severe inflammation or ulcers in my stomach or intestines.

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I have a severe blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, 1 month, 3 month, 6 month, 9 month, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, 1 month, 3 month, 6 month, 9 month, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, 1 month, 3 month, 6 month, 9 month, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Changed in pain scale from Day 0 to 12 months

Weight change compared to baseline

Secondary study objectives

Change in HOMA-IR levels compared to baseline

Change in HgA1c levels compared to baseline

Change in Quality of Life compared to baseline using the Impact of Weight on Quality of Life Lite (IWQOL-Lite) Questionnaire

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BEAM Treatment PatientsExperimental Treatment1 Intervention

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

Group II: Lifestyle Modification Control GroupActive Control1 Intervention

Standard of care lifestyle modification therapy only.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as Bariatric Endoscopic Antral Myotomy (BEAM), work by modifying the stomach's anatomy to influence gastric emptying and hormone levels. BEAM involves antral myotomy, which can accelerate gastric emptying and alter the release of gut hormones like ghrelin, which regulates appetite. These changes help reduce hunger and improve satiety, leading to significant weight loss. This is crucial for obesity patients as it not only aids in weight reduction but also improves metabolic health, potentially resolving comorbid conditions like type 2 diabetes and hypertension.

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