NCT05866081 Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
| NCT ID | NCT05866081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Stone, Kidney |
| Study Type | INTERVENTIONAL |
| Enrollment | 792 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 792 participants in total. It began in 2023-06-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently) * Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan * Access to means of communication with the study team (email, text messaging, and/or telephone) * Adequate independent cognitive function and English language proficiency to complete study surveys * Written informed consent Exclusion Criteria: * Planned bilateral ureteroscopy * Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney * Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion) * Anatomic or functional solitary kidney * Planned secondary or staged ureteroscopy * Planned use of ureteral access sheath * Pregnancy * Patients who use opiate medication daily for greater than 3 months to manage a painful condition Second Stage Exclusion Criteria: * ureteral perforation * unanticipated anatomic abnormality * greater than expected bleeding * ureteral dilation greater than 12 French * ureteral access sheath utilized * failed ureteroscopy * no or incomplete lithotripsy performed * unable to complete case due to medical or anesthetic event.
Contact & Investigator
Khurshid Ghani, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05866081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stone, Kidney. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05866081 currently recruiting?
Yes, NCT05866081 is actively recruiting participants. Contact the research team at Esekulos@med.umich.edu for enrollment information.
Where is the NCT05866081 trial being conducted?
This trial is being conducted at Tucson, United States, Gainesville, United States, Indianapolis, United States, Ann Arbor, United States and 11 additional locations.
Who is sponsoring the NCT05866081 clinical trial?
NCT05866081 is sponsored by University of Michigan. The principal investigator is Khurshid Ghani, MD at University of Michigan. The trial plans to enroll 792 participants.
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