EGPSS for Weight Management in an in Vivo Human Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endoscopic gastric purse-string suturing.
- Who it may be relevant to
- Registry conditions: Obesity, Mild. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model
Overview
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.
Detailed description
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.
Interventions
- Procedure endoscopic gastric purse-string suturing
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 outcome measures
- Percent Total Weight Loss (%TWL) measured by calibrated digital scale [Time frame: Baseline and 3 months post-procedure]
Secondary outcome measures (6)
- Percent Excess Weight Loss (%EWL) measured by calibrated digital scale [Time frame: Baseline and 3 months]
- Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal [Time frame: Baseline and 3 months]
- Gastric fundus volume (magnetic resonance imaging, MRI) [Time frame: Baseline and 3 months]
- Fasting plasma ghrelin and leptin (ELISA) [Time frame: Baseline and 3 months]
- Insulin resistance (HOMA-IR) [Time frame: Baseline and 3 months]
- Procedure-related adverse events (ASGE lexicon severity grading) [Time frame: Day 0 to Month 3]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The fifth Medical Center of Chinese PLA General Hospital — Beijing
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07186959 · EGPSS for weight management