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Enrolling by Invitation

NCT Number: NCT07186959

EGPSS for Weight Management in an in Vivo Human Model

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.

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Key information

About this study

The global prevalence of obesity has increased over the past five decades. Endoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management and have emerged as promising alternatives for treating obesity and related metabolic disorders (including type 2 diabetes and nonalcoholic fatty liver disease). Christopher et al. reported that ablation of the gastric fundus mucosa induces mucosal fibrosis; the resulting fibrotic tissue impedes fundic expansion and promotes satiety. However, fundic mucosal ablation may cause extensive and irreversible injury, increasing the risks of perforation, infection, bleeding, and other complications. A minimally invasive endoscopic therapy that inhibits fundic expansion while minimizing surgical trauma and preserving reversibility is therefore desirable.

Based on this rationale, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce the volume of the gastric fundus. EGPSS employs a specially designed endoclip in combination with an endoloop to appose the fundic mucosa and restrict fundic expansion. This procedure may be suitable for short-term weight management. Safety and feasibility have been demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Percent Total Weight Loss (%TWL) measured by calibrated digital scale

    Time frame: Baseline 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.

Secondary outcomes

  1. Percent Excess Weight Loss (%EWL) measured by calibrated digital scale

    Time frame: Baseline and 3 months

    %EWL calculated as (baselineweight-follow-upweight)÷(baselineweight-idealweightatBMI25kg/m

    ) × 100%.

  2. Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal

    Time frame: Baseline and 3 months

    Satiety assessed using a 100-mm VAS (0 = not at all, 100 = extremely) at 0, 15, 30, 60 minutes after a 400-kcal standardized liquid meal; area under the curve (AUC) computed.

  3. Gastric fundus volume (magnetic resonance imaging, MRI)

    Time frame: Baseline and 3 months

    Fundic volume quantified by MRI volumetry during a standardized water-challenge protocol; primary read by a blinded radiologist; volume reported in mL and Δ from baseline.

  4. Fasting plasma ghrelin and leptin (ELISA)

    Time frame: Baseline and 3 months

    Morning fasting venous samples analyzed by validated ELISA; concentrations reported in pg/mL (ghrelin) and ng/mL (leptin).

  5. Insulin resistance (HOMA-IR)

    Time frame: Baseline and 3 months

    HOMA-IR calculated from fasting glucose (mmol/L) and insulin (µU/mL): insulin × glucose ÷ 22.5.

  6. Procedure-related adverse events (ASGE lexicon severity grading)

    Time frame: Day 0 to Month 3

    All adverse events captured and coded using the ASGE lexicon with severity grade and relatedness adjudicated by the safety monitor.

Sponsors and collaborators

Lead sponsor

Liu Yan

Other

Registry information

Official study title

A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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