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ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss) (AW2)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty
Fundic Mucosal Ablation with ERBE HybridAPC
Apollo ESG
Sponsored by
True You Weight Loss
About
Eligibility
Locations
Arms
Outcomes
Full info

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 True You Weight Loss 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 LossRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Arm Description

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session

Outcomes

Primary Outcome Measures

Rate of Safety Complications
Occurrence of Grade III - V complications according to the Clavien-Dindo classification
Rate of Adverse Events
Occurrence of Adverse Events and Serious Adverse Events

Secondary Outcome Measures

Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measure percent change in total body weight over time following FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

Full Information

First Posted
August 8, 2023
Last Updated
September 18, 2023
Sponsor
True You Weight Loss
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1. Study Identification

Unique Protocol Identification Number
NCT05992103
Brief Title
ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)
Acronym
AW2
Official Title
Single-Stage Gastric Fundus Ablation and Endoscopic Sleeve Gastroplasty for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
April 14, 2025 (Anticipated)
Study Completion Date
May 15, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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-ESG) on total body weight loss (TBWL) as well as the incidence of adverse events. Fundic ablation will be followed with ESG, to evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that the combined endoscopic intervention (FA-ESG) will result in significant weight loss while maintaining an acceptable safety profile

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
Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
Arm Type
Experimental
Arm Description
Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session
Intervention Type
Procedure
Intervention Name(s)
Fundic Ablation 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
Rate of Safety Complications
Description
Occurrence of Grade III - V complications according to the Clavien-Dindo classification
Time Frame
Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Title
Rate of Adverse Events
Description
Occurrence of Adverse Events and Serious Adverse Events
Time Frame
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 Outcome Measure Information:
Title
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Description
Measure percent change in total body weight over time following FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Time Frame
Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
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 True You Weight Loss 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chase Wooley, BS
Phone
(919) 336-4171
Email
chase@trueyouweightloss.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher E McGowan, MD, MSCR
Email
drmcgowan@trueyouweightloss.com
Facility Information:
Facility Name
True You Weight Loss
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chase Wooley, BS
Phone
919-336-4171
Email
Chase@TrueYouWeightLoss.com
First Name & Middle Initial & Last Name & Degree
Christopher E McGowan, MD, MSCR

12. IPD Sharing Statement

Citations:
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3915747
Citation
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Results Reference
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Citation
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Results Reference
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Links:
URL
http://www.trueyouweightloss.com
Description
Sponsor Site

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

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