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The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position

NCT03266770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-01

Study results available
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Summary

Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use is associated with many morbidities which can affect patients' quality of life. However, replacement of the distal portion of the stent with a thin material may reduce bladder irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing irritative bladder symptoms.

Conditions

  • Ureteral Obstruction

Interventions

DEVICE

RELIEF Stent

The RELIEF stent will be placed under cystoscopy. The stent with pusher will be placed over the guidewire and inserted. The pusher will be positioned, the guidewire will be removed, and the pusher will be retracted. The position of the stent will be confirmed by x-ray (C-arm).

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Kyle Scarberry, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2022-12-12
Completion
2022-12-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266770 on ClinicalTrials.gov