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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

（ - ） 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.

Exclusion Criteria:

（ - ） 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;

（ - ） 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;

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A single arm study, only investigational product

Arm Description

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

Outcomes

Primary Outcome Measures

Changes of MRI-PDFF

Changes of MRI-PDFF at device retrieval

Secondary Outcome Measures

Changes of MRI-PDFF

Changes of MRI-PDFF at 12 and 24 weeks after device retrieval

Changes of liver stiffness measurement (LSM)

Changes of liver stiffness measurement (LSM) at device retrieval, and 12 and 24 weeks after device retrieval

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

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

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 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

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

Histological changes

Histological changes at device retrieval

Evaluation on the usability of the device

Use abdominal X-ray evaluate Device implantation status

Full Information

NCT ID

NCT05495139

First Posted

August 7, 2022

Last Updated

August 8, 2022

Sponsor

Hangzhou Tangji Medical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05495139

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hangzhou Tangji Medical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A single arm study, only investigational product

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes of MRI-PDFF

Description

Changes of MRI-PDFF at device retrieval

Time Frame

24 weeks after device implantation procedure(Visit 7)

Secondary Outcome Measure Information:

Title

Changes of MRI-PDFF

Description

Changes of MRI-PDFF at 12 and 24 weeks after device retrieval

Time Frame

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

Title

Changes of liver stiffness measurement (LSM)

Description

Changes of liver stiffness measurement (LSM) at device retrieval, and 12 and 24 weeks after device retrieval

Time Frame