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

December 5, 2023 updated by: True You Weight Loss

Single-Stage Gastric Fundus Ablation and Endoscopic Sleeve Gastroplasty for Weight Loss

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • True You Weight Loss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 True You Weight Loss
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session
Device: Fundic Mucosal Ablation with ERBE HybridAPC
Fundic mucosal ablation utilizing approved ERBE HybridAPC
Device: Apollo ESG
Using only Apollo ESG as approved per label
Procedure: Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty
Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Safety Complications
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
Occurrence of Grade III - V complications according to the Clavien-Dindo classification
Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Rate of 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
Occurrence of Adverse Events and Serious Adverse Events
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 Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Total Body Weight Loss (TBWL) from Baseline
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
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
Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

True You Weight Loss

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Estimated)

April 14, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-002

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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