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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, 1 month, 3 month, 6 month, 9 month, 12 months
Awards & highlights
BEAM Trial Summary
This trial will study the effects of a stomach procedure (BEAM) on weight loss and related factors, such as gastric emptying and hormones, in people with obesity.
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.Check my eligibility
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.See study design
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.
BEAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an endoscopy for weight loss surgery assessment.
Select...
I am between 18 and 70 years old.
Select...
I am a candidate for weight loss surgery or procedures.
BEAM Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Changed in pain scale from Day 0 to 12 months
Weight change compared to baseline
Secondary outcome measures
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 moreBEAM 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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,857 Total Patients Enrolled
45 Trials studying Obesity
78,155 Patients Enrolled for Obesity
Erbe USA IncorporatedOTHER
9 Previous Clinical Trials
1,081 Total Patients Enrolled
4 Trials studying Obesity
75 Patients Enrolled for Obesity
Christopher C. Thompson, MD, MScPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
5,106 Total Patients Enrolled
3 Trials studying Obesity
5,106 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health issue that makes endoscopy risky for me.I have long-term stomach pain.I have had an endoscopy for weight loss surgery assessment.Currently enrolled in the CWMW lifestyle modification program.I am between 18 and 70 years old.I have an untreated thyroid condition affecting my weight.I am not on medications that could stop me from losing weight.I have a serious stomach condition, like cancer or a precancerous disease.Your body mass index (BMI) is between 30 and 50.I am a candidate for weight loss surgery or procedures.I do not have severe heart or lung disease, recent heart attacks, uncontrolled high blood pressure, or a need for NSAIDs.You have ongoing mental health issues that would make it hard for you to take part in a program to change your lifestyle.I am not taking medication that affects how my stomach empties.I have had surgery on my digestive system.You are currently smoking.I have an untreated H. pylori infection.You are pregnant or have recently given birth.I have been treated with opioids in the past year.I have had surgery on the opening of my stomach.I have a blockage in my digestive tract.I have varices in my esophagus or stomach, or gastropathy due to portal hypertension.I do not have severe inflammation or ulcers in my stomach or intestines.My mental health is excellent.I have a severe blood clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: BEAM Treatment Patients
- Group 2: Lifestyle Modification Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experimental program accept participants of all ages, including those under forty?
"According to the requirements, patients wishing to take part must be aged between 18 and 70. Furthermore, there are a total of 208 clinical trials available for individuals younger than 18 years old and 732 specifically designed for those over 65."
Answered by AI
Is enrollment for this experiment currently open?
"This research project, first announced on February 1st 2023, is no longer seeking participants. However, per the clinicaltrials.gov database there are still numerous other trials actively trying to recruit patients in need of help."
Answered by AI
What are the goals of this trial?
"The main objective of this trial, assessed over a 12-month time frame, is to measure Adverse Events. Secondary endpoints include Gastric Emptying measured by GEBT, ghrelin levels detected in blood samples and alterations in insulin metabolic profiles determined through laboratory analysis."
Answered by AI
Am I eligible to partake in this research endeavor?
"This clinical trial will select 20 individuals, aged 18 to 70, who are currently in the midst of weight loss. In addition to meeting these age criteria, potential participants must also meet other requirements such as a BMI between 30-50 kg/m2, being mentally sound and able to sign informed consent forms and attending all subsequent follow-up visits."
Answered by AI
Who else is applying?
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Both my parents received surgery and it was very helpful for their weight loss journey.
PatientReceived 1 prior treatment
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