Health TrialsbyHealthPanel

EUS Procedures Using RIVOS™ EUS Access Device

ConditionsPancreatic Fluid CollectionsBiliary ObstructionPancreatic Duct ObstructionChronic PancreatitisPancreatic Cancer Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOrlando Health, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device

Disqualifiers

Age < 18 years

Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device

Trial population

Patients undergoing EUS-guided interventions

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EUS-guided intervention using the RIVOS™ EUS access device

    Device

    EUS-guided intervention using the RIVOS™ EUS access device

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients requiring interventional EUS procedures1 intervention

Trial outcomes

Primary outcomes

1

Technical success

Rate of technical success in patients undergoing EUS-guided procedures

Time frame
1 day

Secondary outcomes

1

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.

Time frame
4 weeks
2

Adverse events

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

Time frame
4 weeks
3

Procedure duration

Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.

Time frame
1 day
4

Hospital admission

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

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orlando Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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