Clinical trial NCT06420700: Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
Official title: A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: ghrelin
fundus ablation
gastric mucosal ablation
endoscopic sleeve gastroplasty
ESG-MAX
obesity
ablation
hunger
True You Weight Loss
Lead sponsor: True You Weight Loss
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (Age ≥ 18 years and ≤ 65 and BMI ≥ 28 and ≤55 kg/m²) who underwent combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss locations (Cary, NC and Atlanta, GA) regardless of their voluntary participation in the research

Brief summary: The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.

Detailed description: Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. While the 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. The proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic hormone, which has been linked to increased calorie intake and weight gain. Studies have observed reduced levels of ghrelin along multiple timepoints following LSG and this has been attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting ghrelin levels, ostensibly due to fundic-sparing. In a preliminary, first-in-human study conducted by True You Weight Loss (ABLATE Weight), gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months. In this 10-patient study, fundus ablation was performed safely in all cases and without serious adverse events. A subsequent first-in-human study (ABLATE WEIGHT 2) further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session. Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile. By constructing a multi-site, prospective registry, the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty (ESG) at True You Weight Loss.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and ≤ 65 years old
2. BMI ≥ 28 and ≤55 kg/m²
3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
4. Ability to give informed consent
5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
6. Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research

Exclusion Criteria:

1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
3. Patients who are pregnant or breast-feeding.
4. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
6. At the discretion of the PI for subject safety

Primary outcomes:
measure: Percent Change in Total Body Weight Loss (TBWL) from Baseline
timeFrame: 12 Months
Secondary outcomes:
measure: Percent Change in Total Body Weight Loss (TBWL) from Baseline
timeFrame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
measure: Percent Excess Weight Loss from Baseline (EWL)
timeFrame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
measure: Change in Body Mass Index (BMI) from Baseline
timeFrame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: True You Weight Loss
state: Georgia
city: Cary
country: United States
facility: True You Weight Loss
state: North Carolina
Study officials:
References:
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