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.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• （ - ） 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.
Locations
Other Locations
China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Ziru Liu
lzr@tangjimedical.com
0571-86702039
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 10
Treatments
Experimental: A single arm study, only investigational product
To evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Tangji Medical Technology Co., Ltd.