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NCT05866081 · ClinicalTrials.gov registry record · NA
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
A NA study of Stone, Kidney and Stone Ureter, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 792
- Enrollment target
- 16
- Study locations
NCT05866081 is a NA study of Stone, Kidney and Stone Ureter that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 792 participants. The trial reports 16 study locations across 6 states.
The verdict
NCT05866081, a NA study of Stone, Kidney and Stone Ureter, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 792 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. The study team hypothesizes that: * Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts. * Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.
Conditions Studied
Interventions
- DEVICE Standard of care stent placement
- OTHER No stent placement
- OTHER Surveys
Study Locations (16)
Michigan
- University of Michigan Health System - Ann Arbor
- University of Michigan Health System - Brighton
- Cadillac Munson Hospital - Cadillac
- St. Joseph Health System Chelsea Hospital - Chelsea
- St. Joseph Mercy Health (Trinity) - Chelsea
- Henry Ford Health System - Detroit
- Corewell Health Buttersworth Hospital - Grand Rapids
- E.W Sparrow Hospital - Lansing
- MyMichigan Medical Center Midland - Midland
- Michigan Institute of Urology Town Center Ambulatory Surgery Center - Troy
New York
- Monte Fiore - Brooklyn
- Mount Sinai - New York
Arizona
- University of Arizona - Tucson
Florida
- UF Health Shands Hospital - Gainesville
Indiana
- Indiana University Department of Urology - Indianapolis
North Carolina
- UNC Hospital - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2026-05-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05866081
The ClinicalTrials.gov registry entry for NCT05866081 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 792 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stone, Kidney appearing as the primary indexed condition, and to 3 interventions - of which Standard of care stent placement is the first listed.
NCT05866081 reports 16 study locations spanning 6 distinct geographic areas - top geographies include Michigan, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT05866081 about?
NCT05866081 is a clinical study titled "Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative". This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the...
What is the current status of trial NCT05866081?
This trial is currently recruiting. It is a NA study. The enrollment target is 792 participants. The study started on 2023-06-01. Estimated completion is 2026-05-01.
What conditions does trial NCT05866081 study?
This clinical trial studies the following conditions: Stone, Kidney, Stone Ureter.
What interventions are being tested in trial NCT05866081?
The interventions under investigation include: Standard of care stent placement (DEVICE), No stent placement (OTHER), Surveys (OTHER).
Who is sponsoring clinical trial NCT05866081?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05866081 being conducted?
This trial has 16 study locations across Arizona, Florida, Indiana, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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