Clinical obesity
Conditions
Interventions
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 (pl
Sponsors
Yotsuya Medical Cube
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events related to this treatment -Adverse events/reactions will be assessed using the JCOG Postoperative Complications Criteria (Clavien-Dindo Classification), ver. 2.0. Efficacy: Weight loss (percentage of total body weight loss, %TWL) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, Body weight, BMI, waist circumference, and body composition 2, Glycemic, lipid, and blood pressure profiles 3, Clinical effects on obesity-related comorbidities 4, Changes in medication (dosage, type, and cost) 5, Quality of life assessment (SF-36, GIQOL) | — |
Countries
Japan
Contacts
Public ContactRenzo Yokoyama
Yotsuya Medical Cube Weight Loss and Metabolic Surgery Center
Outcome results
None listed