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

NCT06420700 | Recruiting

• 1 other identifier: RGT-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

ghrelin; fundus ablation; gastric mucosal ablation; endoscopic sleeve gastroplasty; ESG-MAX; obesity; ablation; hunger; True You Weight Loss

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 Months

Secondary Outcomes (3)

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

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

• Percent Excess Weight Loss from Baseline (EWL)

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

• Change in Body Mass Index (BMI) from Baseline

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

Study Arms (1)

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.

Procedure: Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Interventions

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty PROCEDURE

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

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Age ≥ 18 years and ≤ 65 years old
• BMI ≥ 28 and ≤55 kg/m²
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research

You may not qualify if:

• Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
• Patients who are pregnant or breast-feeding.
• Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
• At the discretion of the PI for subject safety

Sponsors & Collaborators

• True You Weight Loss: lead

Study Sites (2)

True You Weight Loss

Atlanta, Georgia, 30342, United States

RECRUITING

True You Weight Loss

Cary, North Carolina, 27513, United States

RECRUITING

Related Publications (9)

• 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 BACKGROUND

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

  PMID: 17200702 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Study Sponsor Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

(Optional) Gastric fundus biopsy

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chase Wooley, BS

CONTACT

(919) 336-4171; Chase@trueyouweightloss.com

Shannon Casey, BS, MS

CONTACT

(919) 391-7843; Shannon@trueyouweightloss.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

US (2)