NCT06671119

Brief Summary

The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 5, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

October 31, 2024

Last Update Submit

November 1, 2024

Conditions

Obesity and Obesity-related Medical ConditionsObesity and OverweightObesity PreventionObesity Recidivism

Keywords

obesityobesity and overweightendoscopic bariatric therapyablationgastric mucosal ablationGMA

Outcome Measures

Primary Outcomes (1)

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

    Measure percent change in total body weight over time following endoscopic GMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

    6 Months

Secondary Outcomes (8)

  • Rate of Safety Complications according to Clavien-Dindo Classification

    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 (AE)

    Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

  • Post-operative Pain Assessment

    Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

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

    Month 12

  • Quality of Life Assessment

    6 Months

  • +3 more secondary outcomes

Study Arms (1)

Gastric Mucosal Ablation (GMA) following sleeve gastrectomy

EXPERIMENTAL

Subjects will undergo endoscopic Gastric Mucosal Ablation (GMA) following sleeve gastrectomy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Device: Gastric Mucosal Ablation (GMA)

Interventions

Gastric Mucosal Ablation (GMA)DEVICE

Endoscopic Gastric Mucosal Ablation (GMA) after sleeve gastrectomy

Gastric Mucosal Ablation (GMA) following sleeve gastrectomy

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients who have:
  • BMI of 30 kg/m2 or greater, AND
  • regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%
  • Must have undergone SG at least three years before the time of enrollment
  • Age range: 22 - 60 years
  • Must agree to refrain from using weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dual GLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counter weight loss medications or supplements throughout the study.
  • Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
  • Must agree not to donate blood during participation in the study.
  • Should be able to comply with study requirements, understand, and sign the Informed Consent Form.
  • Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.
  • Should have a history of failure to lose weight using conventional diet and lifestyle therapies.
  • Must have reliable access to wifi and/or internet services.
  • Must express willingness to comply with the substantial lifelong dietary restrictions required by the procedure.

You may not qualify if:

  • Inadequate response to sleeve gastrectomy
  • Patients requiring exogenous insulin.
  • HbA1c \> 8.5%
  • Pregnant or breast-feeding or intending to get pregnant during the study.
  • Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
  • Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).
  • Change in diabetic treatment within the last three months.
  • Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors.
  • GLP-1 use in the preceding 6 months.
  • Known autoimmune disease, other than autoimmune thyroid disease, which is adequately replaced, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
  • Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
  • History of diabetic gastroparesis.
  • Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis.
  • Acute gastrointestinal illness in the previous 7 days.
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

True You Weight Loss

Cary, North Carolina, 27513, United States

RECRUITING

Related Publications (2)

  • Bulajic M, Vadala di Prampero SF, Boskoski I, Costamagna G. Endoscopic therapy of weight regain after bariatric surgery. World J Gastrointest Surg. 2021 Dec 27;13(12):1584-1596. doi: 10.4240/wjgs.v13.i12.1584.

    PMID: 35070065BACKGROUND

  • Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.

    PMID: 27048439BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher McGowan, MD, MSCR

    True You Weight Loss

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Casey, MS

CONTACT

(919) 391-7843Shannon@trueyouweightloss.com

Chase Wooley, BS

CONTACT

(984) 345-2988Chase@trueyouweightloss.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Founder/Co-CEO/Chief Medical Officer

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

December 1, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 5, 2024

Record last verified: 2024-10

Locations

US(1)