Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059145) titled 'Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity' on Sept. 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Yotsuya Medical Cube

Condition: Condition - Clinical obesity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Partial gastric plication (PGP) is a novel, minimally invasive bariatric procedure in which the lateral (greater curvature) portion of the stomach is folded inward (plication) laparoscopically, thereby reducing gastric volume to induce weight loss and improve obesity-related comorbidities. The aim of this clinical trial is to evaluate the safety and efficacy of PGP. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Partial gastric plication (PGP) is a novel minimally invasive treatment for obesity that reduces gastric volume by laparoscopically folding the outer (greater curvature) side of the stomach inward (plication), with the aim of achieving weight loss and improving obesity-related health disorders.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1, Age between 18 and 65 years 2, Body mass index (BMI) equal to or greater than 25 kg/m2 at the time of enrollment 3, Presence of at least one obesity-related comorbidity (as defined in the 2022 Clinical Practice Guidelines for Obesity) 4, Ability to comply with the study protocol and attend follow-up visits 5, Provision of written informed consent Key exclusion criteria - 1. History of cardiovascular events within the past 6 months 2, History of congestive heart failure, angina pectoris, or peripheral vascular disease 3, Considered unsafe for surgery based on cardiac stress testing or 12-lead electrocardiogram 4, History of pulmonary embolism or thrombophlebitis within the past 6 months 5, Active malignancy 6, Severe anemia or coagulation disorders 7, Serum creatinine equal to or greater than 1.5 mg/dL 8, History of gastric surgery (cases with extremely low risk of recurrence, such as post-endoscopic resection for early gastric cancer, may be considered individually) 9, History of gastric or duodenal ulcer within the past 6 months 10, History of intra-abdominal infection (e.g., abscess, sepsis) 11, History of organ transplantation 12, HIV positivity, active tuberculosis, malaria, hepatitis B or C, liver cirrhosis, or inflammatory bowel disease 13, Pregnancy, breastfeeding, or planning to become pregnant within the next 2 years 14, Alcohol or drug dependence within the past 5 years 15, Active psychosocial or psychiatric disorders 16, Concurrent participation in another research protocol 17, Chronic or debilitating disease likely to interfere with protocol compliance 18, Any other condition judged by the investigator to render the subject ineligible Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 26 Day Date of IRB - 2025 Year 06 Month 08 Day Anticipated trial start date - 2025 Year 06 Month 08 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067656

Disclaimer: Curated by HT Syndication.