The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region

Not Applicable

Recruiting

• Conditions: Liver; Fibrosis

• Registration Number: NCT06561529
• Lead Sponsor: MDCECRO LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-13
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN score) at 6 months after procedure (i.e. device implantation)	6 months	* Percentage of NAFLD activity score (NAS) reduction without worsening of fibrosis stage; * Percentage of improvement in fibrosis stage and no deterioration in NAFLD activity score (NAS)

Secondary Outcome Measures

Name	Time	Method
Relative percentage change in Total Weight Loss (TWL%) and changes in BMI	12 months	Relative percentage change in Total Weight Loss (TWL%) and changes in BMI at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in blood glucose-related markers (fasting insulin, fasting glucose, fasting C-peptide)	12 months	Changes in blood glucose-related markers (fasting insulin, fasting glucose, fasting C-peptide, insulin resistance (HOMA-IR)) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in liver fibrosis-related markers (Forns Index)	12 months	Changes in liver fibrosis-related markers (Forns Index) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in liver fibrosis-related markers (Fibrosis-4 Index (FIB-4))	12 months	Changes in liver fibrosis-related markers (Fibrosis-4 Index (FIB-4)) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in liver fibrosis-related markers (S Index)	12 months	Changes in liver fibrosis-related markers (S Index) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in liver fibrosis-related markers (AST to Platelet Ratio Index (APRI))	12 months	Changes in liver fibrosis-related markers (AST to Platelet Ratio Index (APRI)) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in liver inflammation/injury-related markers (ALT, AST, GGT, ALP, Total Bilirubin, Direct Bilirubin)	12 months	Changes in liver inflammation/injury-related markers (ALT, AST, GGT, ALP, Total Bilirubin, Direct Bilirubin) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in Fibroscan Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM)	12 months	Changes in Fibroscan Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in blood lipid-related markers (total cholesterol [TC], triglyceride [TG], high-density lipoprotein C [HDL-C], low-density lipoprotein C [LDL-C]), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, lipoprotein(a))	12 months	Changes in blood lipid-related markers (total cholesterol \[TC\], triglyceride \[TG\], high-density lipoprotein C \[HDL-C\], low-density lipoprotein C \[LDL-C\]), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, lipoprotein(a)) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.
Changes in blood glucose-related markers (insulin resistance (HOMA-IR))	12 months	Changes in blood glucose-related markers (insulin resistance (HOMA-IR)) at 12 weeks after device implantation, at the time of device removal, 12 weeks after device removal, and 24 weeks after device removal.

Trial Locations

Locations (2)

Digestive Diseases Centre "GASTRO"; 🇱🇻 Riga, Latvia

REUH, hospital "lnfectology center of Latvia"; 🇱🇻 Riga, Latvia