RIVOS Feasibility (MBO)

Not Applicable

Not yet recruiting

• Conditions: Malignant Biliary Obstruction

• Registration Number: NCT06666699
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-07-01
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical Success	Day 0 Study Procedure	Defined as (1) access of the target biliary duct, as confirmed via imaging, (2) ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and (3) ability to create a cautery fistula for accessory device passage
Safety	Day 0 Study Procedure through Day 7 Post-Study Procedure	Study device- and study procedure-related serious adverse events
Device Performance	Day 0 Study Procedure	Evaluated per the following criteria (1) ability to gain access to the target structure, (2) ability to maintain access to the target structure, (3) ability to visualize device during necessary procedural steps, and (4) ability to create a cautery fistula for accessory device passage

Trial Locations

Locations (3)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Georges Pompidou European Hospital; 🇫🇷 Paris, France

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India