Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)

NCT ID: NCT06420700

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2028-01-31

Brief Summary

The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.

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, ostensibly due to fundic-sparing. In a preliminary, first-in-human study conducted by True You Weight Loss (ABLATE Weight), gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months. In this 10-patient study, fundus ablation was performed safely in all cases and without serious adverse events. A subsequent first-in-human study (ABLATE WEIGHT 2) further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session. Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile. By constructing a multi-site, prospective registry, the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty (ESG) at True You Weight Loss.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

All patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study.

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Intervention Type: PROCEDURE

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity

Interventions

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years and ≤ 65 years old

2. BMI ≥ 28 and ≤55 kg/m²

3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.

4. Ability to give informed consent

5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.

6. Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research

Exclusion Criteria

1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria

2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.

3. Patients who are pregnant or breast-feeding.

4. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.

5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.

6. At the discretion of the PI for subject safety

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

True You Weight Loss

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

True You Weight Loss

Atlanta, Georgia, United States

Site Status: RECRUITING

True You Weight Loss

Cary, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chase Wooley, BS

Role: CONTACT

Chase@trueyouweightloss.com

(919) 336-4171

Shannon Casey, BS, MS

Role: CONTACT

Shannon@trueyouweightloss.com

(919) 391-7843

Facility Contacts

Chase Wooley, BS

Role: primary

Chase@trueyouweightloss.com

919-336-4171

Shannon Casey, BS, MS

Role: backup

Shannon@trueyouweightloss.com

(919) 391-7843

Chase Wooley, BS

Role: primary

Chase@trueyouweightloss.com

919-336-4171

Shannon Casey, BS, MS

Role: backup

Shannon@trueyouweightloss.com

(919) 391-7843

References

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Reference Type: BACKGROUND

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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

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Reference Type: BACKGROUND

PMID: 23794092 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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

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Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

Reference Type: BACKGROUND

PMID: 20189503 (View on PubMed)

Related Links

http://www.trueyouweightloss.com

Study Sponsor Website

Other Identifiers

RGT-001

Identifier Type: -

Identifier Source: org_study_id