Chinese University of Hong Kong
Shatin, Hong Kong
Location status: Recruiting
Location contact
Jenny Ho
CONTACT
Philip Wai Yan Chiu, FRCSEd(Gen), MD
CONTACT
Stephen Ka Kei Ng, FRCSEd(Gen)
CONTACT
Stephen Ng, FRCSEd(Gen)
CONTACT
NCT Number: NCT06622382
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Shatin, Hong Kong
Location status: Recruiting
Jenny Ho
CONTACT
Philip Wai Yan Chiu, FRCSEd(Gen), MD
CONTACT
Stephen Ka Kei Ng, FRCSEd(Gen)
CONTACT
Stephen Ng, FRCSEd(Gen)
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haemostasis is confirmed.
Time frame: baseline, 1,3,6,12 months
Weight change compared to baseline
Time frame: within 30 days of procedure
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1 day
successful completion of endoscopic procedures
Time frame: baseline, 1,3,6,12 months
Serum ghrelin levels compared to baseline
Time frame: baseline, 1,3,6,12 months
Blood pressure and anti-hypertensive medication use compared to baseline
Time frame: baseline, 1,3,6,12 months
Lipid profile compared to baseline
Time frame: 3 days
measured by visual analogue scale (0:no pain - 10:worst pain)
Time frame: baseline, 1,6,12 months
measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best)
Time frame: baseline, 1,6,12 months
measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Time frame: baseline, 1,3,6,12 months
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
AST, ALT, ALP and GGT level compared to baseline
Time frame: baseline, 1,3,6,12 months
level compared to baseline
Time frame: baseline, 1,3,6,12 months
NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
Time frame: baseline, 1,3,6,12 months
Change in sleep quality
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
Acronym: BEAM pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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