Chinese University of Hong Kong
Shatin, Hong Kong
Location status: Recruiting
NCT Number: NCT06790329
Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure.
Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile.
This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Shatin, Hong Kong
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed.
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, 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, 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, 3,6,12 months
measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best)
Time frame: baseline, 3,6,12 months
measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Time frame: baseline, 3,6,12 months
measured by Three-Factor Eating Questionnaire (TFEQ-R21) - (21:worst - 84:best)
Time frame: baseline, 3,6,12 months
levels compared to baseline
Time frame: baseline, 3,6,12 months
levels compared to baseline
Time frame: baseline, 3,6,12 months
levels compared to baseline
Time frame: baseline, 3,6,12 months
level compared to baseline
Time frame: baseline, 3,6,12 months
NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
Interested in participating?
Request InfoChinese University of Hong Kong
Other
Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study
Acronym: ESG-FUMA
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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