RIVOS Feasibility (MBO)

NCT06666699 | Withdrawn FDA Device

• 1 other identifier: E7189
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 3

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.

Conditions

Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (3)

• Technical Success

  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

  Day 0 Study Procedure

• Safety

  Study device- and study procedure-related serious adverse events

  Day 0 Study Procedure through Day 7 Post-Study Procedure

• Device Performance

  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

  Day 0 Study Procedure

Study Arms (1)

RIVOS

EXPERIMENTAL

Device: EUS access device

Interventions

EUS access device DEVICE

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

RIVOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age or older
• Patient willing and able to provide written informed consent and comply with specified study visits

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Georges Pompidou European Hospital

Paris, 75015, France

Location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location

Study Officials

• Sundeep Lakhtakia, MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 31, 2024
• Study Start: August 31, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IN (1); FR (1)