Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07675122

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUHK Medical Centre, Shatin, Hong Kong

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Excess body weight loss (%EBWL)

    Time frame: 12 months post-procedure

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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: within 30 days post-procedure

    Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

  2. Body fat percentage

    Time frame: 12 months post-procedure

    Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 12

  3. Duodenal and faecal microbiome

    Time frame: 12 months post-procedure

    changes in duodenal and faecal microbiome from baseline to Month 24

  4. Improvement of liver steatosis

    Time frame: 12 months post-procedure

    Changes in CAP (S0:best - S3:worst) on Fibroscan

  5. Improvement of liver fibrosis

    Time frame: 12 months post-procedure

    Changes in LMS (F0:best - F4:worst) on Fibroscan

  6. Change in Quality of Life

    Time frame: 12 months post-procedure

    measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 12

  7. HbA1c

    Time frame: 12 months post-procedure

    Change in HbA1c (%) from baseline to Month 12

  8. Duodenal mucosal changes

    Time frame: 12 months post-procedure

    Changes in duodenal mucosal structures on histology from baseline to Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Ivy Study coordinator

CONTACT

[email protected]

Stephen Ng, FRCSEd

CONTACT

[email protected]

+85235052956

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • CUHK Medical Centre

Registry information

Official study title

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

Acronym: DJBS-OMS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.