AW2: ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)
Study Details
Study Description
Brief Summary
The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. When fundic mucosal ablation is paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG within the same endoscopic session should be made available to patients as part of a comprehensive weight loss strategy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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, 8 ostensibly due to fundic-sparing. In this study, the investigators propose to investigate the effects of fundic ablation (FA-ESG) on total body weight loss (TBWL) as well as the incidence of adverse events. Fundic ablation will be followed with ESG, to evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that the combined endoscopic intervention (FA-ESG) will result in significant weight loss while maintaining an acceptable safety profile
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session |
Procedure: Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty
Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity
Device: Fundic Mucosal Ablation with ERBE HybridAPC
Fundic mucosal ablation utilizing approved ERBE HybridAPC
Device: Apollo ESG
Using only Apollo ESG as approved per label
|
Outcome Measures
Primary Outcome Measures
- Rate of Safety Complications [Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12]
Occurrence of Grade III - V complications according to the Clavien-Dindo classification
- Rate of Adverse Events [Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12]
Occurrence of Adverse Events and Serious Adverse Events
Secondary Outcome Measures
- Percent Change in Total Body Weight Loss (TBWL) from Baseline [Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12]
Measure percent change in total body weight over time following FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects aged 21-65
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Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
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History of at least one unsuccessful dietary effort to lose body weight
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Willing and able to participate in the study procedures
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Understand and voluntarily sign the informed consent
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Approved ESG candidate at True You Weight Loss
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Access to internet
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Reliable transportation to and from Cary, North Carolina surrounding area
Exclusion Criteria:
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Younger than 21 years of age
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Older than 65 years of age
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Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
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Milk and/or soy allergies
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History of any stomach manipulation (including repair of hiatal hernia)
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History of disordered eating
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Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
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Hemoglobin A1c > 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis
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Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
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Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
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Patients who are pregnant or who plan to become pregnant during study duration
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Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
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Patients on chronic anticoagulation
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History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
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Concurrent use of weight loss medications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | True You Weight Loss | Cary | North Carolina | United States | 27513 |
Sponsors and Collaborators
- True You Weight Loss
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.
- Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.
- Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
- Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.
- Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9.
- Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.
- Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.
- Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0.
- 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.
- Vijayvargiya P, Chedid V, Wang XJ, Atieh J, Maselli D, Burton DD, Clark MM, Acosta A, Camilleri M. Associations of gastric volumes, ingestive behavior, calorie and volume intake, and fullness in obesity. Am J Physiol Gastrointest Liver Physiol. 2020 Aug 1;319(2):G238-G244. doi: 10.1152/ajpgi.00140.2020. Epub 2020 Jul 6.
- PS-002