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ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

Sponsor
True You Weight Loss (Other)
Overall Status
Recruiting
CT.gov ID
NCT05578703
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
42.7
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fundic ablation sequentially in combination with endoscopic sleeve gastroplasty
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss
Actual Study Start Date :
Nov 9, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

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

Procedure: Fundic ablation sequentially in combination with endoscopic sleeve gastroplasty
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 endoscopic sleeve gastroplasty (ESG), to evaluate the combined impact of FA and ESG (FA-ESG).
Other Names:
  • FA - ESG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Fasting Plasma Ghrelin Levels [Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18]

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

    2. Change from Baseline in Timed Standardized Nutrient Drink Test [Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18]

      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)

    3. Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI) [Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18]

      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

    4. Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS) [Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18]

      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)

    5. Percent Change in Total Body Weight Loss (TBWL) from Baseline [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]

      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

    6. Change from Baseline in Weight Efficacy Life-Style Questionnaire Short Form (WEL-SF) composite score [Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18]

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

    Secondary Outcome Measures

    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]

      FA and FA-ESG safety will be measured by the rate of serious adverse events (SAEs), adverse events (AEs), and accommodative symptom occurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    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

    • Principal Investigator: Christopher E McGowan, MD, MSCR, CEO/ Medical Director

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    True You Weight Loss
    ClinicalTrials.gov Identifier:
    NCT05578703
    Other Study ID Numbers:
    • PS-001
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Nov 15, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Weight Loss

    Study Results

    No Results Posted as of Nov 15, 2022