N/A
N=95
Impact Ureteral Sheath Design During Ureteroscopy
Renal Stone · Nephrolithiasis · Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT03349099 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With Successful Sheath Placement — 37; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cook Flexor (Device); Boston Scientific Navigator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Sheath Placement |
37; 39 | — |
| SECONDARY Number of Participants With Injury to the Ureter |
36; 27 | — |
| SECONDARY Ease of Sheath Placement |
2.9; 3.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients planned for ureteroscopy
- Current CT scan within 90-days before the operation
- Able to give informed consent
- Ages 18 years and older
Exclusion Criteria
- Inability to give informed consent
- Age less than 18 years
- Pregnant
- Stones in the ureter
- Having previous ipsilateral ureteral or renal surgery within 90 days
- Having stents placed in ipsilateral ureter within 90 days
Data sourced from ClinicalTrials.gov (NCT03349099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.