MedTrace Logo

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

NCT05495139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-06-26

No results posted yet for this study

Summary

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

Conditions

  • Nonalcoholic Fatty Liver Disease

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Hangzhou Tangji Medical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • Lungen Lu · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Baiwen Li · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2025-12-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495139 on ClinicalTrials.gov