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ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

Primary Purpose

Obesity

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty

Fundic Mucosal Ablation with ERBE HybridAPC

Apollo ESG

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

True You Weight Loss

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Arm Description

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty

Outcomes

Primary Outcome Measures

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

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)

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

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)

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

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)

Secondary Outcome Measures

Rate of safety and adverse events

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

Full Information

NCT ID

NCT05578703

First Posted

October 6, 2022

Last Updated

February 24, 2023

Sponsor

True You Weight Loss

1. Study Identification

Unique Protocol Identification Number

NCT05578703

Brief Title

ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

Official Title

Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 9, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

True You Weight Loss

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Arm Type

Experimental

Arm Description

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty

Intervention Type

Procedure

Intervention Name(s)

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fundic Mucosal Ablation with ERBE HybridAPC

Intervention Description

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Intervention Type

Device

Intervention Name(s)

Apollo ESG

Intervention Description

Using only Apollo ESG as approved per label

Primary Outcome Measure Information:

Title

Change from Baseline in Fasting Plasma Ghrelin Levels

Description

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

Time Frame

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

Title

Change from Baseline in Timed Standardized Nutrient Drink Test

Description

Time Frame

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

Title

Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)

Description

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

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Rate of safety and adverse events

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher E McGowan, MD, MSCR

Organizational Affiliation

CEO/ Medical Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

True You Weight Loss

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27513

Country

United States

12. IPD Sharing Statement

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Links:

URL

http://www.trueyouweightloss.com

Description

Sponsor Site

Learn more about this trial

ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

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