RIVOS Feasibility (MBO)

Design Optimization of RIVOS EUS Access Device - A Feasibility Study

The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:

• Can the device be used to gain and maintain access to target anatomy?
• Does the device have a clinically acceptable safety profile?
• How does the device perform overall?

All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.

Inclusion Criteria:

• Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
• Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
• 18 years of age or older
• Patient willing and able to provide written informed consent and comply with specified study visits

Exclusion Criteria:

• Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure

• Abnormal coagulopathy:

  • INR >1.5 and not correctable
  • presence of bleeding disorder
  • platelets <50,000 mm3

• Patient with contraindication to use of electrical devices

• Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study

• Patient from a vulnerable population

• Current participation in another investigational drug or device study that could interfere with the endpoints of this study