Pancreatic Fluid CollectionsNCT07696572
EUS Procedures Using RIVOS™ EUS Access Device
An observational study of Pancreatic Fluid Collections and Biliary Obstruction, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fluid Collections, Biliary Obstruction, Pancreatic Duct Obstruction
- What is being tested?
- EUS-guided intervention using the RIVOS™ EUS access device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to Dec 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing EUS-guided interventions
Who may be able to join
- Age ≥ 18 years
- All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device
Who cannot join
- Age < 18 years
- Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health Digestive Health Institute
Orlando, Florida, 32806
Ji Young Bang, MD MPH, 321-842-2273, jiyoung.bang@orlandohealth.com
Barbara J Broome, barbara.broome@orlandohealth.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Fluid Collections, Biliary Obstruction, Pancreatic Duct Obstruction, Chronic Pancreatitis, Pancreatic Cancer Non-resectable
- Being tested
- EUS-guided intervention using the RIVOS™ EUS access device
- Keywords
- EUS-guided bile duct drainage, EUS-guided pancreatogastrostomy, Endoscopic ultrasound
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided intervention using the RIVOS™ EUS access deviceDevice
EUS-guided intervention using the RIVOS™ EUS access device
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring interventional EUS procedures | Patients requiring interventional EUS procedures Receives: Device: EUS-guided intervention using the RIVOS™ EUS access device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Rate of technical success in patients undergoing EUS-guided procedures
Measured: 1 day
Secondary outcomes (4)
Treatment success
Rate of treatment success, defined as the resolution of symptoms and/or radiological findings from underlying disease at 4-weeks following index intervention.
Measured: 4 weeks
Adverse events
Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
Measured: 4 weeks
Procedure duration
Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.
Measured: 1 day
Hospital admission
Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start13 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Fluid CollectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696572
- Sponsor's protocol ID
- 2457590
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device
- ClinicalTrials.gov ID
- NCT07696572
- Acronym / sponsor ID
- 2457590
- Conditions
- Pancreatic Fluid Collections, Biliary Obstruction, Pancreatic Duct Obstruction, Chronic Pancreatitis, Pancreatic Cancer Non-resectable
- Keywords
- EUS-guided bile duct drainage, EUS-guided pancreatogastrostomy, Endoscopic ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring interventional EUS procedures | – | Device: EUS-guided intervention using the RIVOS™ EUS access devicePatients requiring interventional EUS procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing EUS-guided interventions
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided intervention using the RIVOS™ EUS access deviceEUS-guided intervention using the RIVOS™ EUS access device | Device | Patients requiring interventional EUS procedures |
Primary outcome
Technical success
Time frame: 1 day
Rate of technical success in patients undergoing EUS-guided procedures
4 secondary outcomes
Treatment success
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
Procedure duration
Time frame: 1 day
Hospital admission
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fluid Collections and Biliary Obstruction, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Young Bang, MD MPH (321-842-2273, jiyoung.bang@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.