NCT07675122

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 20, 2026

Last Update Submit

June 25, 2026

Conditions

ObesityMetabolic Syndrome (MetS)

Keywords

duodenal-jejunal bypass sleeveDJBSDJBL

Outcome Measures

Primary Outcomes (1)

  • Excess body weight loss (%EBWL)

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

    12 months post-procedure

Secondary Outcomes (8)

  • Incidence of adverse events

    within 30 days post-procedure

  • Body fat percentage

    12 months post-procedure

  • Duodenal and faecal microbiome

    12 months post-procedure

  • Improvement of liver steatosis

    12 months post-procedure

  • Improvement of liver fibrosis

    12 months post-procedure

  • +3 more secondary outcomes

Study Arms (1)

Duodenal-jejunal bypass sleeve (DJBS)

EXPERIMENTAL

3 months implantation of DJBS

Procedure: Implantation of duodenal-jejunal bypass sleeve

Interventions

Implantation of duodenal-jejunal bypass sleevePROCEDURE

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.

Duodenal-jejunal bypass sleeve (DJBS)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese University of Hong Kong

Shatin, Hong Kong

Location

CUHK Medical Centre

Shatin, Hong Kong

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Stephen Ng, FRCSEd

    Prince of Wales Hospital, the Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Ng, FRCSEd

CONTACT

+85235052956stephenng@surgery.cuhk.edu.hk

Ivy Study coordinator

CONTACT

ivypoon@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2026

First Posted

June 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2029

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations

HK(2)