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Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

NCT05026710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-10-28

Study results available
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Summary

This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy.

Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery).

The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.

Conditions

  • Renal Stone
  • Ureteral Stone

Interventions

DEVICE

Silicone (Coloplast Imajin Hydro) ureteral stent

During the end of the standard of care ureteroscopy the silicone stent will be placed.

DEVICE

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.

Sponsors & Collaborators

Principal Investigators

  • Khurshid Ghani, MD, MS, FRCS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2024-07-01
Completion
2024-08-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05026710 on ClinicalTrials.gov