BEAM Treatment Patients for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MAWeight Loss+5 MoreBariatric Endoscopic Antral Myotomy - Procedure
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Weight Loss
  • Obesity
  • Gastroparesis
  • Mild Obesity
  • Morbid Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Screening, 1 month, 3 month, 6 month, 9 month, 12 months

Month 12
Adverse Events
Changed in pain scale from Day 0 to 12 months
Screening, 1 month
Radiological (Dynamic MRI) gastric emptying rate (minutes) of contrast transit from esophagus, through stomach to small intestine compared to baseline compared to baseline
Month 12
Change in Quality of Life compared to baseline using the Impact of Weight on Quality of Life Lite (IWQOL-Lite) Questionnaire
Month 12
Change in HOMA-IR levels compared to baseline
Change in HgA1c levels compared to baseline
Change in glucose levels compared to baseline
Change in insulin metabolic profiles compared to baseline
Gastric Emptying compared to baseline
Ghrelin levels compared to baseline
Radiological (Upper GI Series) gastric emptying rate (minutes) of barium transit from esophagus through stomach to small intestine compared to baseline
Month 12
Weight change compared to baseline

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Lifestyle Modification Control Group
1 of 2
BEAM Treatment Patients
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: BEAM Treatment Patients · No Placebo Group · N/A

BEAM Treatment Patients
Procedure
Experimental Group · 1 Intervention: Bariatric Endoscopic Antral Myotomy · Intervention Types: Procedure
Lifestyle Modification Control GroupNoIntervention Group · 1 Intervention: Lifestyle Modification Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening, 1 month, 3 month, 6 month, 9 month, 12 months

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,498 Previous Clinical Trials
10,483,165 Total Patients Enrolled
1 Trials studying Weight Loss
60 Patients Enrolled for Weight Loss
Erbe USA IncorporatedOTHER
8 Previous Clinical Trials
659 Total Patients Enrolled
Christopher C. Thompson, MD, MScPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
5,006 Total Patients Enrolled
2 Trials studying Weight Loss
5,006 Patients Enrolled for Weight Loss

Eligibility Criteria

Age 18 - 70 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to be in good mental health.
You are able to undergo weight loss procedures that require an endoscopy or surgery.
You have a body mass index (BMI) between 30 and 50, which means you may be overweight or obese.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.