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Access Sheath and Stent Trial

NCT07297953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-12-22

No results posted yet for this 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

  • Kidney Stone
  • Ureteral Stone

Interventions

OTHER

Surveys

Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.

Sponsors & Collaborators

Principal Investigators

  • Khurshid Ghani, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • United States

Study Locations

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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 NCT07297953 on ClinicalTrials.gov