Actively Recruiting
The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
Led by MDCECRO LLC · Updated on 2025-05-08
10
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
Sponsors
M
MDCECRO LLC
Lead Sponsor
H
Hangzhou Tangji Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.
CONDITIONS
Official Title
The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Body mass index (BMI) of 30 kg/m² or higher
- Suspected or confirmed NASH liver fibrosis based on biochemical tests (PRO-C3 >14 ng/mL or ELF ≥9), fibroscan transient elastography ≥8.5 kPa, or liver biopsy within 2 years showing stage 1B, 2, or 3 fibrosis with stable weight and medications
- Liver biopsy confirming NASH within 6 months before randomization showing fibrosis stage 1-3, NAS ≥3, and scores of at least 1 for steatosis, ballooning, and lobular inflammation
- No effective weight loss after 3 months of lifestyle modification and non-invasive treatments (non-diabetic patients less than 5% weight loss, diabetic patients less than 3%)
- Able and willing to provide informed consent and comply with all study procedures and assessments
You will not qualify if you...
- Liver cirrhosis
- Secondary obesity caused by endocrine or hypothalamic disorders
- Chronic daily use of systemic anti-inflammatory or corticosteroid medications for more than 1 week (excluding low-dose aspirin or inhaled corticosteroids)
- Less than one year of continuous treatment before baseline with hypoglycemic drugs known to cause weight loss
- Diagnosis of type 1 diabetes
- Severely impaired islet β cell function (low C-peptide levels or flat C-peptide release curve)
- Significant iron deficiency or iron deficiency anemia
- Coagulation dysfunction or recent use of systemic anti-inflammatory or anti-coagulation medication
- Severe liver and kidney dysfunction with serum creatinine ≥180 µmol/L
- New York Heart Association Class III or higher heart function
- History of ERCP, cholecystitis, or liver abscess
- Duodenal or gastric ulcers, or pancreatitis
- Gallstones ≥20 mm with symptoms
- Unstable thyroid dysfunction despite treatment
- Digestive tract hemorrhage or potential hemorrhage
- Gastrointestinal tract anomalies preventing device placement
- History of bowel obstruction or related diseases in the past year
- History of systemic lupus erythematosus or scleroderma
- Severe uncontrolled infections
- Poor general condition or endoscopic contraindications
- Pregnancy or planning pregnancy
- Alcohol dependence or substance abuse
- Unstable psychiatric disorders
- Participation in another investigational study without completed follow-up
- Allergy to the investigational device components
- Other conditions deemed unsuitable by investigators
- Positive for hepatitis B, hepatitis C, or HIV infection (with some exceptions based on investigator judgment)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
REUH, hospital "lnfectology center of Latvia"
Riga, Riga, Latvia, LV1013
Actively Recruiting
2
Digestive Diseases Centre "GASTRO"
Riga, Latvia, LV-1079
Actively Recruiting
Research Team
M
MDCE CRO
CONTACT
D
Dmitry Luchinin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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