ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

NCT ID: NCT05578703

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2026-06-30

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.

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) on circulating plasma ghrelin, satiation via standard nutrient drink test, and total body weight loss (TBWL), as well as the incidence of adverse events. Fundic ablation will be followed sequentially with ESG, to evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that, compared to baseline, FA-ESG will diminish fasting ghrelin levels, improve satiation, and induce a TBWL ≥ 15% at 12 months.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty

Group Type: EXPERIMENTAL

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty

Intervention Type: PROCEDURE

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

Fundic Mucosal Ablation with ERBE HybridAPC

Intervention Type: DEVICE

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Apollo ESG

Intervention Type: DEVICE

Using only Apollo ESG as approved per label

Interventions

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty

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

Intervention Type: PROCEDURE

Fundic Mucosal Ablation with ERBE HybridAPC

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Intervention Type: DEVICE

Apollo ESG

Using only Apollo ESG as approved per label

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects aged 21-65

2. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²

3. History of at least one unsuccessful dietary effort to lose body weight

4. Willing and able to participate in the study procedures

5. Understand and voluntarily sign the informed consent

6. Approved ESG candidate at TYWL

7. Access to internet

8. Reliable transportation to and from Cary, North Carolina surrounding area

Exclusion Criteria

1. Younger than 21 years of age

2. Older than 65 years of age

3. Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels

4. Milk and/or soy allergies

5. History of any stomach manipulation (including repair of hiatal hernia)

6. History of disordered eating

7. 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

8. Hemoglobin A1c > 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis

9. Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine

10. Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents

11. Patients who are pregnant or who plan to become pregnant during study duration

12. Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration

13. Patients on chronic anticoagulation

14. History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.

15. Concurrent use of weight loss medications.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

True You Weight Loss

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher E McGowan, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

CEO/ Medical Director

Locations

True You Weight Loss

Cary, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 3915747 (View on PubMed)

Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.

Reference Type: BACKGROUND

PMID: 17200702 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22231739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23794092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31592891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16105401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32193741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32628074 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31788546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12061909 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35533995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33226548 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26042918 (View on PubMed)

Related Links

http://www.trueyouweightloss.com

Sponsor Site

Other Identifiers

PS-001

Identifier Type: -

Identifier Source: org_study_id