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ClinicalTrials.gov ID

NCT07675122

Lead Sponsor

Chinese University of Hong KongOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

20Estimated

Last Update Posted

Jun 30, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Jul 31, 2028Estimated

Completion Date

Jul 31, 2029Estimated

Official Title

Endoscopic Duodenal-jejunal Bypass Sleeve for Treatment of Obesity and Metabolic Syndrome - a Multicenter Pilot Study

Brief Summary

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

Detailed Description

This is a prospective, single-arm study enrolling individuals with obesity. Participants will receive 3 months implantation of duodenal-jejunal bypass sleeve (DJBS). They will be followed for another 9 months after removal of DJBS to assess the outcomes.

• Obesity
• Metabolic Syndrome (MetS)

• Implantation of duodenal-jejunal bypass sleeve

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

CUHK Medical CentreUNKNOWN

wongkhmo@cuhk.edu.hk+85239466888