NCT07696572

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Pancreatic Fluid CollectionsBiliary ObstructionPancreatic Duct ObstructionChronic PancreatitisPancreatic Cancer Non-resectable

Keywords

EUS-guided bile duct drainageEUS-guided pancreatogastrostomyEndoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

  • Technical success

    Rate of technical success in patients undergoing EUS-guided procedures

    1 day

Secondary Outcomes (4)

  • Treatment success

    4 weeks

  • Adverse events

    4 weeks

  • Procedure duration

    1 day

  • Hospital admission

    4 weeks

Study Arms (1)

Patients requiring interventional EUS procedures

Patients requiring interventional EUS procedures

Device: EUS-guided intervention using the RIVOS™ EUS access device

Interventions

EUS-guided intervention using the RIVOS™ EUS access deviceDEVICE

EUS-guided intervention using the RIVOS™ EUS access device

Patients requiring interventional EUS procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing EUS-guided interventions

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ji Young Bang, MD MPH

CONTACT

321-842-2273jiyoung.bang@orlandohealth.com

Barbara J Broome

CONTACT

321-841-3742barbara.broome@orlandohealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)