Clinical trial

Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Metabolic Syndrome

Opening soon · Not applicable · 1 countries · Registry ID NCT07675122

Opening soonNot applicableInterventional

What this study is about

This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Metabolic Syndrome (MetS)

Full registry criteria

Inclusion Criteria: * Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome Exclusion Criteria: * Patients who have lost more than 5 kg of weight in the past three months * Patients who have used glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the past three months * Patients who are currently taking weight loss drugs such as orlistat * Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month * iron deficiency or iron deficiency anemia * Gastrointestinal malformations, such as patients with gastrointestinal atresia or other patients who will cause gastrointestinal implantation failure * Those with a history of cholecystitis and liver abscess * There is a known infection, and the type of disease and the severity of the infection are not suitable for use by clinicians * coagulation dysfunction; * Severe liver and kidney dysfunction, AST /ALT \> 2.5 times, total bilirubin \> 35 μmol/L, blood creatinine concentration greater than 180 μmol/L * Patients with ASA IV \& V * Drug or alcohol abuse addiction or suffering from uncontrollable mental illness * Duodenal bulb ulcer, gastric ulcer or previous and existing pancreatitis * Coronary heart disease, angina, cardiac function grade III or above, or pulmonary dysfunction * Patients who have undergone ERCP before * Patients with potential bleeding or telangiectasia in the stomach, esophagus, small intestine and other parts * Have a history of systemic lupus erythematosus, scleroderma * Those who have contraindications to endoscopy (judged by clinicians) * Pregnant women or those who are preparing to become pregnant * Those who are allergic to nickel-titanium * Any other situation that the clinician deems unsuitable for participation in this product

Treatments and study arms

Implantation of duodenal-jejunal bypass sleeve

Procedure

The duodenal-jejunal bypass sleeve (DJBS) is a 60 cm thin, flexible tube. It is implanted into the duodenum using an endoscopy procedure and is kept in place for 3 months. After 3 months, it will be removed endoscopically.

Primary outcomes

Excess body weight loss (%EBWL)12 months post-procedure

Percent excess body weight loss (%EBWL) from baseline to Month 12

Study locations

2 locations were listed when this page was built. The first 40 are shown.

CUHK Medical Centre🇭🇰 Shatin, Hong Kong
Simon Wong, FRCSEdContact
Simon Wong, FRCSEdSub Investigator
Chinese University of Hong Kong🇭🇰 Shatin, Hong Kong
Stephen Ng, FRCSEdContact
Ivy Study coordinatorContact
Stephen Ng, FRCSEdPrincipal Investigator