N/A Completed N=95 Randomized Single-blind Treatment

Impact Ureteral Sheath Design During Ureteroscopy

Renal Stone · Nephrolithiasis · urolithiasis

Source: ClinicalTrials.gov NCT03349099 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcomePrimary: Number of Participants With Successful Sheath Placement — 37; 39 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.