Clinical trial

EGPSS for Weight Management in an in Vivo Human Model

Invitation only · Not applicable · 1 countries · Registry ID NCT07186959

Invitation onlyNot applicableInterventional

What this study is about

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and other complications. To restrain fundic expansion while minimizing surgical trauma and preserving reversibility, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce gastric volume. This procedure may be suitable for short-term weight management. Safety and feasibility were demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Mild

Full registry criteria

Inclusion criteria: * Patients with a body mass index (BMI) of 24-35 kg / m²; * Patients accepted Lifestyle modifications, pharmacological interventions for weight loss which were unsuccessful or experienced a weight rebound; * Patients willing to loss weight; * Obese patients with metabolic disorders. Exclusion criteria: * Women who are planning to conceive, pregnant, or breastfeeding; * Patients who are suffering from severe organ failure requiring hospitalization; * Patients who have undergone gastrectomy; * Patients allergic to anesthetics.

Treatments and study arms

endoscopic gastric purse-string suturing

Procedure

A dual-tail endoloop will be introduced into the stomach with endoscopic forceps, and will be secured to the gastric wall using endoscopic clips. An endoscope hook was used to tighten both tails of the endoloop until all the clips converged.

Primary outcomes

Percent Total Weight Loss (%TWL) measured by calibrated digital scaleBaseline and 3 months post-procedure

Body weight recorded using a calibrated digital scale (kg). %TWL calculated as (baselineweight-follow-upweight)÷baselineweight × 100%. Measurements obtained under fasting conditions, light clothing, no shoes.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The fifth Medical Center of Chinese PLA General Hospital🇨🇳 Beijing, Beijing Municipality, China

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