EUS Procedures Using RIVOS™ EUS Access Device

July 6, 2026 updated by: Orlando Health, Inc.

Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device

This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound (EUS)-guided interventions are becoming the first-line treatment of various pancreaticobiliary disorders such as malignant biliary obstruction, access to bile duct or pancreatic duct after failed ERCP, and drainage of pancreatic, peripancreatic or intraabdominal fluid collections. However, given the lack of dedicated devices for performing these complex interventions, accessories used to perform endoscopic retrograde cholangiopancreatography (ERCP) are currently being used off-label to perform most interventional EUS procedures.

The RIVOS™ EUS access device is a novel, FDA approved device that has been specifically developed for performing EUS-guided interventions. The device has a sharp trocar tip to allow access to the target organ, a flexible access cannula to allow contrast injection and passage of a guidewire, and an electrocautery-tip to facilitate the creation of a fistula. This innovative design is expected to simplify the technical aspects of the procedure and improve the safety profile for these complex endoscopic interventions.

The aim of this study is to evaluate the technical and treatment outcomes in patients undergoing standard of care, interventional EUS-guided procedures in patients with pancreaticobiliary disorders using the RIVOS™ EUS access device.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing EUS-guided interventions

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device

Exclusion Criteria:

  • Age < 18 years
  • Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients requiring interventional EUS procedures
Device: EUS-guided intervention using the RIVOS™ EUS access device
EUS-guided intervention using the RIVOS™ EUS access device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 1 day
Rate of technical success in patients undergoing EUS-guided procedures
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 4 weeks
Rate of treatment success, defined as the resolution of symptoms and/or radiological findings from underlying disease at 4-weeks following index intervention.
4 weeks
Adverse events
Time Frame: 4 weeks
Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
4 weeks
Procedure duration
Time Frame: 1 day
Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.
1 day
Hospital admission
Time Frame: 4 weeks
Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2457590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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