Health TrialsbyHealthPanel

REvision of VSG with Ablation of the Mucosa Procedure

ConditionsObesity and Obesity-related Medical ConditionsObesity and OverweightObesity PreventionObesity Recidivism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-60
SponsorDr. Christopher McGowan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inadequate response to sleeve gastrectomy

Patients requiring exogenous insulin.

HbA1c > 8.5%

Pregnant or breast-feeding or intending to get pregnant during the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Gastric Mucosal Ablation (GMA)

    Device

    Endoscopic Gastric Mucosal Ablation (GMA) after sleeve gastrectomy

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Gastric Mucosal Ablation (GMA) following sleeve gastrectomyExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 Months

Secondary outcomes

1

Rate of Safety Complications according to Clavien-Dindo Classification

Occurrence of complications according to the Clavien-Dindo classification

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

Rate of Adverse Events (AE)

Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.

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

Post-operative Pain Assessment

Visual Analog Scale pain score at baseline compared to postoperative follow-up visits. The VAS Pain Scores range from 0 (minimum) to 10 (maximum), where 0 represents no pain and 10 represents the maximum level of pain, with higher scores indicating greater intensity of postoperative pain.

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

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

Time frame
Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Christopher McGowan

Lead sponsor

True You Weight Loss

Sponsor institution

Source ClinicalTrials.gov
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