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RIVOS Feasibility (MBO)

NCT06666699 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-22

No results posted yet for this study

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

DEVICE

EUS access device

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Sundeep Lakhtakia, MD · Asian Institute of Gastroenterology

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-05-30
Completion
2026-05-30
FDA Device
Yes

Countries

  • Belgium
  • France
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666699 on ClinicalTrials.gov