NCT06666699

RIVOS Feasibility (MBO)

Design Optimization of RIVOS EUS Access Device - A Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Biliary Obstruction

Interventions

Type	Name	Description
DEVICE	EUS access device	The intervention involves the use of an EUS access device to gain access to the bile duct via hepaticogastrostomy.

Timeline

• Start date: 2025-08-31
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2024-10-31
• Last updated: 2025-09-22

Locations

3 sites across 3 countries: Belgium, France, India

Regulatory

• FDA-regulated device study