ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

NCT05578703 | Active Not Recruiting FDA Device

• 1 other identifier: PS-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate the effects of fundic ablation (FA) 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. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially 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 should be made available to patients as part of a comprehensive weight loss strategy.

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Fasting Plasma Ghrelin Levels

  Change from baseline for the quantitative determination of fasting ghrelin, total plasma measured by EIA/ELISA laboratory assays

  Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18

• Change from Baseline in Timed Standardized Nutrient Drink Test

  Measure timed consumption of a standardized nutrient drink test utilizing a sensation of satiation visual analogue scale. The severity of symptoms range from 0 (no symptoms) to 5 (maximum or unbearable fullness/satiation) and will measure volume to comfortable fullness (VTF) and maximum tolerated volume (MTV)

  Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18

• Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)

  Assess the severity of patient-reported gastroparesis symptoms. The GCSI gastroparesis symptoms score ranges from 0-none to 5-very severe. High scores reflect greater symptom severity

  Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18

• Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS)

  Rate the responses to the DAILY EATS questionnaire. The DAILY EATS questionnaire is designed to better understand patient's definitions, experience, and importance, of eating-related factors on a scale of 0-10. The DAILY EATS is a 5-item, patient-reported measure evaluating key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety)

  Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18

• Percent Change in Total Body Weight Loss (TBWL) from Baseline

  Measure percent change in total body weight over time following FA alone and FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18

• Change from Baseline in Weight Efficacy Life-Style Questionnaire Short Form (WEL-SF) composite score

  Measure of eating self-efficacy consisting of 8-items on a scale of 0 (not at all confident) to 10 (very confident)

  Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18

Secondary Outcomes (1)

• Rate of safety and adverse events

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18

Study Arms (1)

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

EXPERIMENTAL

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty

Procedure: Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty; Device: Fundic Mucosal Ablation with ERBE HybridAPC; Device: Apollo ESG

Interventions

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty PROCEDURE

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

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Fundic Mucosal Ablation with ERBE HybridAPC DEVICE

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Apollo ESG DEVICE

Using only Apollo ESG as approved per label

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 TYWL
• 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 (13)

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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.

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• 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

• Chial HJ, Camilleri C, Delgado-Aros S, Burton D, Thomforde G, Ferber I, Camilleri M. A nutrient drink test to assess maximum tolerated volume and postprandial symptoms: effects of gender, body mass index and age in health. Neurogastroenterol Motil. 2002 Jun;14(3):249-53. doi: 10.1046/j.1365-2982.2002.00326.x.

  PMID: 12061909 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

• Fastenau J, Rozjabek H, Qin S, McLeod L, Nelson L, Ma J, Harris N. Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity. J Patient Rep Outcomes. 2020 Nov 23;4(1):99. doi: 10.1186/s41687-020-00259-w.

  PMID: 33226548 BACKGROUND

• Ames GE, Heckman MG, Diehl NN, Grothe KB, Clark MM. Further statistical and clinical validity for the Weight Efficacy Lifestyle Questionnaire-Short Form. Eat Behav. 2015 Aug;18:115-9. doi: 10.1016/j.eatbeh.2015.05.003. Epub 2015 May 21.

  PMID: 26042918 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 Officials

• Christopher E McGowan, MD, MSCR

  CEO/ Medical Director

  PRINCIPAL INVESTIGATOR

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: October 6, 2022
• First Posted: October 13, 2022
• Study Start: November 9, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

US (1)