Health TrialsbyHealthPanel

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

ConditionNonalcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHangzhou Tangji Medical Technology Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: A single arm study, only investigational productExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes of MRI-PDFF

Changes of MRI-PDFF at device retrieval

Time frame
24 weeks after device implantation procedure(Visit 7)

Secondary outcomes

1

Changes of MRI-PDFF

Changes of MRI-PDFF at 12 and 24 weeks after device retrieval

Time frame
12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
2

Changes of liver stiffness measurement (LSM)

Changes of liver stiffness measurement (LSM) at device retrieval, and 12 and 24 weeks after device retrieval

Time frame
24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
3

Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil)

Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil) at device retrieval, and 12 and 24 weeks after device retrieval

Time frame
24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
4

Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR])

Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance \[e.g. HOMA-IR\]) at device retrieval, and 12 and 24 weeks after device retrieval

Time frame
24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)

Other outcomes

Sponsors and contacts

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

Hangzhou Tangji Medical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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