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NCT07297953 · ClinicalTrials.gov registry record · NA
Access Sheath and Stent Trial
A NA study of Kidney Stone and Ureteral Stone, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 184
- Enrollment target
- 1
- Study location
NCT07297953 is a NA study of Kidney Stone and Ureteral Stone that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 184 participants, roughly in line with the 186-participant average among 28 other Kidney Stone trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT07297953, a NA study of Kidney Stone and Ureteral Stone, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 184 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy. Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion. Hypothesis: \- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
Conditions Studied
Interventions
- OTHER Surveys
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2026-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07297953
The ClinicalTrials.gov registry entry for NCT07297953 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 186-participant average among 28 other Kidney Stone trials with a reported enrollment target. 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 Kidney Stone appearing as the primary indexed condition, and to 1 intervention - of which Surveys is the first listed.
NCT07297953 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT07297953 about?
NCT07297953 is a clinical study titled "Access Sheath and Stent Trial". The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy. Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size ...
What is the current status of trial NCT07297953?
This trial is currently recruiting. It is a NA study. The enrollment target is 184 participants. The study started on 2025-09-24. Estimated completion is 2026-10.
What conditions does trial NCT07297953 study?
This clinical trial studies the following conditions: Kidney Stone, Ureteral Stone.
What interventions are being tested in trial NCT07297953?
The interventions under investigation include: Surveys (OTHER).
Who is sponsoring clinical trial NCT07297953?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07297953 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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