CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
Cook Flexor +1 moredevice
Likely dose
Not stated in record
Key inclusion· 4
  • Planned for ureteroscopy procedure
  • CT scan obtained within 90 days before surgery
  • Age 18 years or older
  • Able to give informed consent
Key exclusion· 4
  • Pregnant
  • Stones located in the ureter
  • Previous ipsilateral ureteral or renal surgery within 90 days
  • Stents placed in ipsilateral ureter within 90 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03349099
NCT03349099N/ACompleted

The Impact of Ureteral Access Sheath Design on Ease of Placement and Ureteral Wall Injury During Flexible Ureteroscopy

The Cleveland Clinic·interventional·Posted Nov 21, 2017·Updated Jan 23, 2018

In Brief

A clinical study evaluating Cook Flexor and Boston Scientific Navigator for Renal Stone and 2 related conditions. Completed, enrolled 95 participants.

Detailed Summary

The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. The investigators will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients. Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not had an ipsilateral procedure within 90 days will be recruited and consented.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 21, 2017
Enrollment StartJun 27, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.6 years ago

Interventions

Cook Flexordevice

ureteral access sheath

Boston Scientific Navigatordevice

ureteral access sheath