Nonalcoholic Fatty Liver DiseaseNCT05495139
Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease
A study testing Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease in people with Nonalcoholic Fatty Liver Disease, run by Hangzhou Tangji Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- （ - ） Males or females with age between 18 and 65 years old;
- （ - ） Diagnosis of nonalcoholic fatty liver disease;
- （ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;
- （ - ） BMI≥24;
- Patients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations.
Who cannot join
- （ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol > 30 g/d for males and > 20 g/d for females);
- （ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;
- （ - ） Unable to cooperate to complete MR examination;
- （ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;
- （ - ） Patients with iron deficiency or iron deficiency anemia;
- （ - ） ALT or AST increased to 8 × upper limit of normal (ULN), and bilirubin increased to 2×ULN;
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- （ - ） Patients with coagulation disorder or haemorrhagic diathesis (platelets <100×109/L);
- （ - ） Patients with duodenal ulcer, or previous or existing pancreatitis;
- （ - ） History of liver abscess;
- （ - ） History of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm);
- （ - ） Patients with gastrointestinal hemorrhage or potential hemorrhage;
- （ - ） Gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract;
- （ - ） Patients with history of intestinal obstruction or related disease in the past year;
- （ - ） Drug abusers or patients with uncontrollable psychiatric disorders;
- （ - ） Patients with any contraindication to endoscopy based on the investigator's judgment;
- （ - ） Pregnancy or lactating women;
- （ - ） Patients who are participating in any other drug or medical device clinical study;
- （ - ） Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Lungen Lu
About this study
Official title: A Small-Sample-Size Clinical Study to Evaluate the Effectiveness and Safety of the Gastric Bypass Stent System in Treatment of Patients With Nonalcoholic Fatty Liver Disease.
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
Read the detailed description
The Gastric Bypass Stent System is intended to be used in Patients with Diagnosis of nonalcoholic fatty liver disease， Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%. In this pivotal, prospective, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver DiseaseDevice
This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 6-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 12 months.
| Study group | Role | What they receive |
|---|---|---|
| A single arm study, only investigational product | Experimental | To evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease. Receives: Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of MRI-PDFF
Changes of MRI-PDFF at device retrieval
Measured: 24 weeks after device implantation procedure(Visit 7)
Secondary outcomes (9)
Changes of MRI-PDFF
Changes of MRI-PDFF at 12 and 24 weeks after device retrieval
Measured: 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of liver stiffness measurement (LSM)
Changes of liver stiffness measurement (LSM) at device retrieval, and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil)
Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil) at device retrieval, and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR])
Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR]) at device retrieval, and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of blood lipids indicators, including triglyceride, total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, and lipoprotein (a)
Changes of blood lipids indicators, including triglyceride, total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, and lipoprotein (a), at device retrieval, and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS)
Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS) at device retrieval, and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Percent changes of body weight and changes of BMI
Percent changes of body weight and changes of BMI at device retrieval and 12 and 24 weeks after device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Histological changes
Histological changes at device retrieval
Measured: 24 weeks after the implantation procedure (Visit 7)
Evaluation on the usability of the device
Use abdominal X-ray evaluate Device implantation status
Measured: 4 weeks after the implantation procedure (Visit 4) 、12 weeks after the implantation procedure (Visit 5)and 18 weeks after the implantation procedure (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start15 Dec 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Tangji Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lungen Lu, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineBaiwen Li, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495139
- Sponsor's protocol ID
- HZTJ03
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small-Sample-Size Clinical Study to Evaluate the Effectiveness and Safety of the Gastric Bypass Stent System in Treatment of Patients With Nonalcoholic Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT05495139
- Acronym / sponsor ID
- HZTJ03
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Tangji Medical Technology Co., Ltd.University, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
Detailed description
The Gastric Bypass Stent System is intended to be used in Patients with Diagnosis of nonalcoholic fatty liver disease， Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%. In this pivotal, prospective, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm study, only investigational product | Experimental | Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver DiseaseTo evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- （ - ） Males or females with age between 18 and 65 years old;
- （ - ） Diagnosis of nonalcoholic fatty liver disease;
- （ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;
- （ - ） BMI≥24;
- Patients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations.
Key exclusion criteria (18 listed)
- （ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol > 30 g/d for males and > 20 g/d for females);
- （ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;
- （ - ） Unable to cooperate to complete MR examination;
- （ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;
- （ - ） Patients with iron deficiency or iron deficiency anemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver DiseaseThis study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 6-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 12 months. | Device | A single arm study, only investigational product |
Primary outcome
Changes of MRI-PDFF
Time frame: 24 weeks after device implantation procedure(Visit 7)
Changes of MRI-PDFF at device retrieval
9 secondary outcomes
Changes of MRI-PDFF
Time frame: 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of liver stiffness measurement (LSM)
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil)
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR])
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of blood lipids indicators, including triglyceride, total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, and lipoprotein (a)
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS)
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Percent changes of body weight and changes of BMI
Time frame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
Histological changes
Time frame: 24 weeks after the implantation procedure (Visit 7)
Evaluation on the usability of the device
Time frame: 4 weeks after the implantation procedure (Visit 4) 、12 weeks after the implantation procedure (Visit 5)and 18 weeks after the implantation procedure (Visit 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lungen Lu principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Baiwen Li principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease in people with Nonalcoholic Fatty Liver Disease, run by Hangzhou Tangji Medical Technology Co., Ltd. at 1 site in China.
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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziru Liu (0571-86702039, lzr@tangjimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of MRI-PDFF (time frame: 24 weeks after device implantation procedure(Visit 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2024.