## Protocol Section
### Identification Module
**NCT ID:** NCT06420700

**Brief Title:** Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)

**Official Title:** A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss

#### Organization Study ID Info
**ID:** RGT-001
#### Organization
**Class:** OTHER
**Full Name:** True You Weight Loss
### Status Module
#### Completion Date
**Date:** 2028-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-01-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** True You Weight Loss

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Obesity

**Keywords:**

- ghrelin

- fundus ablation

- gastric mucosal ablation

- endoscopic sleeve gastroplasty

- ESG-MAX

- obesity

- ablation

- hunger

- True You Weight Loss

### Design Module

#### Bio Spec

**Description:** (Optional) Gastric fundus biopsy

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

**Label:** Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

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

**Name:** Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured percent change in total body weight over time following combined Gastric Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.

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

**Time Frame:** 12 Months

#### Secondary Outcomes

**Description:** Measured percent change in total body weight over time following combined Gastric Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.

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

**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

**Description:** Measured excess weight loss percentage from baseline following combined Gastric Mucosal Ablation. %EWL = (pre-op weight - post op body weight) / (pre-op weight - ideal body weight) \* 100

Ideal Body Weight (IBW):

Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet

**Measure:** Percent Excess Weight Loss from Baseline (EWL)

**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

**Description:** Measured Body Mass Index (BMI) from baseline following combined Gastric Mucosal Ablation. Body Mass Index (BMI) = (Weight in kilograms) / ((Height in meters)\^2)

**Measure:** Change in Body Mass Index (BMI) from Baseline

**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients (Age ≥ 18 years and ≤ 65 and BMI ≥ 28 and ≤55 kg/m²) who underwent combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss locations (Cary, NC and Atlanta, GA) regardless of their voluntary participation in the research

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Chase@trueyouweightloss.com

**Name:** Chase Wooley, BS

**Phone:** (919) 336-4171

**Role:** CONTACT

**Contact 2:**

**Email:** Shannon@trueyouweightloss.com

**Name:** Shannon Casey, BS, MS

**Phone:** (919) 391-7843

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Atlanta

**Contacts:**

***Contact 1:***

- **Email:** Chase@trueyouweightloss.com

- **Name:** Chase Wooley, BS

- **Phone:** 919-336-4171

- **Role:** CONTACT

***Contact 2:***

- **Email:** Shannon@trueyouweightloss.com

- **Name:** Shannon Casey, BS, MS

- **Phone:** (919) 391-7843

- **Role:** CONTACT

***Contact 3:***

- **Name:** Christopher McGowan, MD, MSCR

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Daniel Maselli, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Lauren Donnangelo, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** True You Weight Loss

**State:** Georgia

**Status:** RECRUITING

**Zip:** 30342

**Location 2:**

**City:** Cary

**Contacts:**

***Contact 1:***

- **Email:** Chase@trueyouweightloss.com

- **Name:** Chase Wooley, BS

- **Phone:** 919-336-4171

- **Role:** CONTACT

***Contact 2:***

- **Email:** Shannon@trueyouweightloss.com

- **Name:** Shannon Casey, BS, MS

- **Phone:** (919) 391-7843

- **Role:** CONTACT

***Contact 3:***

- **Name:** Christopher McGowan, MD, MSCR

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Daniel Maselli, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Lauren Donnangelo, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** True You Weight Loss

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27513

### References Module

#### References

**Citation:** Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.

**PMID:** 3915747

**Citation:** Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.

**PMID:** 17200702

**Citation:** 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.

**PMID:** 22231739

**Citation:** Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.

**PMID:** 23794092

**Citation:** McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.

**PMID:** 31592891

**Citation:** Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.

**PMID:** 16105401

**Citation:** Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3.

**PMID:** 19638921

**Citation:** 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.

**PMID:** 32193741

**Citation:** 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.

**PMID:** 20189503

#### See Also Links

**Label:** Study Sponsor Website

**URL:** http://www.trueyouweightloss.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-31
