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

ConditionsFibrosisLiver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMDCECRO LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years.

BMI ≥ 30 kg/m².

Historical biochemical tests for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9

Fibroscan, transient elastography ≥8.5 kPa, controlled attenuation parameter ≥280 dB/m

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Gastric Bypass Stent System

    Device

    The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity holds potential as a non-invasive technique for managing hepatic fibrosis. This clinical investigation will be used to evaluate the safety and performance of the investigational device for the intended use.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment group, subjects will be treated with the Gastric Bypass Stent System implantedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN score) at 6 months after procedure (i.e. device implantation)

* 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)

Time frame
6 months

Secondary outcomes

1

Relative percentage change in Total Weight Loss (TWL%) and changes in BMI

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.

Time frame
12 months
2

Changes in Fibroscan Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM)

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.

Time frame
12 months
3

Changes in liver inflammation/injury-related markers (ALT, AST, GGT, ALP, Total Bilirubin, Direct Bilirubin)

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.

Time frame
12 months
4

Changes in blood glucose-related markers (fasting insulin, fasting glucose, fasting C-peptide)

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MDCECRO LLC

Lead sponsor

Hangzhou Tangji Medical Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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