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.
- Weight Loss
- Obesity
- Gastroparesis
- Mild Obesity
- Morbid Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 9 Secondary · Reporting Duration: Screening, 1 month, 3 month, 6 month, 9 month, 12 months
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Klem ML, Wing RR, Chang CC, Lang W, McGuire MT, Sugerman HJ, Hutchison SL, Makovich AL, Hill JO. A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means. Int J Obes Relat Metab Disord. 2000 May;24(5):573-9. doi: 10.1038/sj.ijo.0801199.
- James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
- Jia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026.
- McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
- Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
- Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.
- Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.
- Saumoy M, Schneider Y, Zhou XK, Shukla A, Kahaleh M, Aronne L, Sharaiha RZ. A single-operator learning curve analysis for the endoscopic sleeve gastroplasty. Gastrointest Endosc. 2018 Feb;87(2):442-447. doi: 10.1016/j.gie.2017.08.014. Epub 2017 Aug 24.
- Marinos G, Eliades C, Raman Muthusamy V, Greenway F. Weight loss and improved quality of life with a nonsurgical endoscopic treatment for obesity: clinical results from a 3- and 6-month study. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):929-34. doi: 10.1016/j.soard.2014.03.005. Epub 2014 Mar 12.
- Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.
- Mohan BP, Chandan S, Jha LK, Khan SR, Kotagiri R, Kassab LL, Ravikumar NPG, Bhogal N, Chandan OC, Bhat I, Hewlett AT, Jacques J, Ponnada S, Asokkumar R, Adler DG. Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Surg Endosc. 2020 Aug;34(8):3352-3367. doi: 10.1007/s00464-019-07135-9. Epub 2019 Oct 3.
- Christopher C. Thompson, MD, MSc 2023. "Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05713071.
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
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
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
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