EGPSS for Weight Management in an in Vivo Human Model

NCT07186959 | Enrolling By Invitation

• 1 other identifier: EGPSS for weight management
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Mild

Keywords

obesity; endoscopic bariatric and metabolic therapy; bariatric surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 3 months post-procedure

Secondary Outcomes (6)

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

  Baseline and 3 months

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

  Baseline and 3 months

• Gastric fundus volume (magnetic resonance imaging, MRI)

  Baseline and 3 months

• Fasting plasma ghrelin and leptin (ELISA)

  Baseline and 3 months

• Insulin resistance (HOMA-IR)

  Baseline and 3 months

Study Arms (1)

Operation group

EXPERIMENTAL

Patients will undergo endoscopic gastric purse-string suturing procedure under endoscope by skilled endoscopist

Procedure: endoscopic gastric purse-string suturing

Interventions

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.

Operation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu Yan: lead

Study Sites (1)

The fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (4)

• Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.

  PMID: 30814686 BACKGROUND

• Maselli DB, Donnangelo LL, Coan B, McGowan CE. How to establish an endoscopic bariatric practice. World J Gastrointest Endosc. 2024 Apr 16;16(4):178-186. doi: 10.4253/wjge.v16.i4.178.

  PMID: 38680199 BACKGROUND

• Simons M, Sharaiha RZ. Updates in metabolic bariatric endoscopy. Dig Endosc. 2024 Feb;36(2):107-115. doi: 10.1111/den.14633. Epub 2023 Aug 9.

  PMID: 37405807 BACKGROUND

• Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14.

  PMID: 36241388 BACKGROUND

MeSH Terms

Conditions

Obesity; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yan Liu

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

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: Director, Head of Gastroenterology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)