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NCT Number: NCT07696572

EUS Procedures Using RIVOS™ EUS Access Device

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

Location status: Recruiting

Location contact

Barbara J Broome

CONTACT

[email protected]

Ji Young Bang, MD MPH

CONTACT

[email protected]

321-842-2273

Ji Young Bang, MD MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-guided intervention using the RIVOS™ EUS access device

Device

EUS-guided intervention using the RIVOS™ EUS access device

Primary outcomes

  1. Technical success

    Time frame: 1 day

    Rate of technical success in patients undergoing EUS-guided procedures

Secondary outcomes

  1. 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.

  2. Adverse events

    Time frame: 4 weeks

    Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.

  3. 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.

  4. Hospital admission

    Time frame: 4 weeks

    Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara J Broome

CONTACT

[email protected]

321-841-3742

Ji Young Bang, MD MPH

CONTACT

[email protected]

321-842-2273

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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