Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Met... | NCT07675122

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

NCT07675122

Sponsor

Chinese University of Hong Kong

Status

Not yet recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obesity
Metabolic Syndrome (MetS)

Interventions

Implantation of duodenal-jejunal bypass sleeve

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Jul 31, 2028Estimated

Completion Date

Jul 31, 2029Estimated

First Submitted Date

Jun 20, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jun 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jun 30, 2026Actual

Name	Class
CUHK Medical Centre	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duodenal-jejunal bypass sleeve (DJBS)	Experimental	3 months implantation of DJBS	Procedure: Implantation of duodenal-jejunal bypass sleeve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Excess body weight loss (%EBWL)	Percent excess body weight loss (%EBWL) from baseline to Month 12	12 months post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events	Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)	within 30 days post-procedure
Body fat percentage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Stephen Ng, FRCSEd	Contact	+85235052956		stephenng@surgery.cuhk.edu.hk
Ivy Study coordinator	Contact			ivypoon@surgery.cuhk.edu.hk

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D009765	Obesity
D024821	Metabolic Syndrome