Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease

NCT05495139 | Recruiting

• 1 other identifier: HZTJ03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Changes of MRI-PDFF

  Changes of MRI-PDFF at device retrieval

  24 weeks after device implantation procedure(Visit 7)

Secondary Outcomes (9)

• Changes of MRI-PDFF

  12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)

• Changes of liver stiffness measurement (LSM)

  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)

  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])

  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)

  24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)

Study Arms (1)

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.

Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease

Interventions

Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease DEVICE

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.

A single arm study, only investigational product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （ - ） 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.

You may not qualify if:

• （ - ） 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;
• （ - ） 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;

Sponsors & Collaborators

• Hangzhou Tangji Medical Technology Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Lungen Lu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Baiwen Li

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziru Liu

CONTACT

0571-86702039; lzr@tangjimedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: December 15, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)