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ObesityDJBS-OMSNCT07675122

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

A study testing Implantation of duodenal-jejunal bypass sleeve in people with Obesity and Metabolic Syndrome (MetS), run by Chinese University of Hong Kong at 2 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Metabolic Syndrome (MetS)
What is being tested?
Implantation of duodenal-jejunal bypass sleeve
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesHong Kong
Study dates
1 Sep 2026to 31 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen Ng, FRCSEd contact

+85235052956

stephenng@surgery.cuhk.edu.hk

Ivy Study coordinator contact

ivypoon@surgery.cuhk.edu.hk

Hong Kong2 sites, 2 recruiting

  • Chinese University of Hong Kong

    Shatin

    Stephen Ng, FRCSEd, +85235052956, stephenng@surgery.cuhk.edu.hk

    Ivy Study coordinator, +85235052956, ivypoon@surgery.cuhk.edu.hk

    Recruiting

  • CUHK Medical Centre

    Shatin

    Simon Wong, FRCSEd, +85239466888, wongkhmo@cuhk.edu.hk

    Simon Wong, FRCSEd

    Not yet recruiting

Other trials in Hong Kong

About this study

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

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

Read the 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.

Being tested
Implantation of duodenal-jejunal bypass sleeve
Keywords
duodenal-jejunal bypass sleeve, DJBS, DJBL
Medical subject headings
Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of duodenal-jejunal bypass sleeveProcedure or surgery

    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.

Study groups in NCT07675122
Study groupRoleWhat they receive
Duodenal-jejunal bypass sleeve (DJBS)Experimental3 months implantation of DJBS
Receives: Procedure: Implantation of duodenal-jejunal bypass sleeve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess body weight loss (%EBWL)

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

    Measured: 12 months post-procedure

Secondary outcomes (8)

  1. Incidence of adverse events

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

    Measured: within 30 days post-procedure

  2. Body fat percentage

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

    Measured: 12 months post-procedure

  3. Duodenal and faecal microbiome

    changes in duodenal and faecal microbiome from baseline to Month 24

    Measured: 12 months post-procedure

  4. Improvement of liver steatosis

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

    Measured: 12 months post-procedure

  5. Improvement of liver fibrosis

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

    Measured: 12 months post-procedure

  6. Change in Quality of Life

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

    Measured: 12 months post-procedure

  7. HbA1c

    Change in HbA1c (%) from baseline to Month 12

    Measured: 12 months post-procedure

  8. Duodenal mucosal changes

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

    Measured: 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675122
Sponsor's protocol ID
CRE-2026.190
Acronym
DJBS-OMS
Status last verified
Sep 2026
First submitted
20 Jun 2026
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of duodenal-jejunal bypass sleeve in people with Obesity and Metabolic Syndrome (MetS), run by Chinese University of Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen Ng, FRCSEd (+85235052956, stephenng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excess body weight loss (%EBWL) (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07675122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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