ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)

NCT05992103 | Unknown FDA Device

• 1 other identifier: PS-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Rate of Safety Complications

  Occurrence of Grade III - V complications according to the Clavien-Dindo classification

  Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

• Rate of Adverse Events

  Occurrence of Adverse Events and Serious 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

EXPERIMENTAL

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; Device: Fundic Mucosal Ablation with ERBE HybridAPC; Device: Apollo ESG

Interventions

Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty PROCEDURE

Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity

Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Fundic Mucosal Ablation with ERBE HybridAPC DEVICE

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Apollo ESG DEVICE

Using only Apollo ESG as approved per label

Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 21-65
• Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
• History of at least one unsuccessful dietary effort to lose body weight
• Willing and able to participate in the study procedures
• Understand and voluntarily sign the informed consent
• Approved ESG candidate at True You Weight Loss
• Access to internet
• Reliable transportation to and from Cary, North Carolina surrounding area

You may not qualify if:

• Younger than 21 years of age
• Older than 65 years of age
• Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
• Milk and/or soy allergies
• History of any stomach manipulation (including repair of hiatal hernia)
• History of disordered eating
• 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
• Hemoglobin A1c \> 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis
• Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
• Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
• Patients who are pregnant or who plan to become pregnant during study duration
• Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
• Patients on chronic anticoagulation
• History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
• Concurrent use of weight loss medications.

Sponsors & Collaborators

• True You Weight Loss: lead

Study Sites (1)

True You Weight Loss

Cary, North Carolina, 27513, United States

Location

Related Publications (10)

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• 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.

  PMID: 22231739 BACKGROUND

• 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.

  PMID: 23794092 BACKGROUND

• 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.

  PMID: 31592891 BACKGROUND

• 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.

  PMID: 16105401 BACKGROUND

• 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.

  PMID: 32193741 BACKGROUND

• 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.

  PMID: 32628074 BACKGROUND

• 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.

  PMID: 31788546 BACKGROUND

• 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.

  PMID: 35533995 BACKGROUND

Related Links

• Sponsor Site

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: September 14, 2023
• Primary Completion: April 14, 2025
• Study Completion: May 15, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

US (1)