NCT07767773 Long-term Safety of UAS-assisted vs Sheathless RIRS in Non-prestented Patients
| NCT ID | NCT07767773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al-Azhar University |
| Condition | Renal Stone Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2026-08-16 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2026-08-16 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This retrospective comparative cohort study will include adult patients who underwent primary RIRS for renal stones ≤20 mm at Al-Azhar University Hospitals between January 2020 and December 2025. Patients will be classified by whether a ureteral access sheath (UAS) was used during the index RIRS, and all eligible patients will be invited for active long-term follow-up (minimum 12 months) to assess the composite outcome of delayed ipsilateral ureteral stricture or new/progressive ipsilateral hydronephrosis and other safety and efficacy outcomes. Propensity-score methods and adjusted regression analyses will be used to control confounding.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years at time of index RIRS. * Primary RIRS performed at Al-Azhar University Hospitals between Jan 1, 2020 and Dec 31, 2025. * Renal stone(s) with maximum diameter ≤20 mm on preoperative imaging. * No ipsilateral ureteral stent or nephrostomy before index RIRS. * Documented operative record specifying whether a UAS was used. * At least 12 months elapsed since index RIRS. * Available contact information allowing invitation for active follow-up. Exclusion Criteria: * Primary ureteral stone treated during the same procedure. * Staghorn or \>20 mm stone burden. * Prior ipsilateral ureteral stricture or reconstructive surgery. * Congenital renal/ureteral anomalies affecting outcome (e.g., horseshoe kidney, duplicated system). * Incomplete operative or preoperative imaging records that preclude determination of eligibility or exposure (UAS use). * Additional ipsilateral ureteral procedure during follow-up that independently causes ureteral narrowing. * Refusal to participate in active follow-up or failure to attend after repeated attempts.
Contact & Investigator
Abul-fotouh Ahmed
PRINCIPAL INVESTIGATOR
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Frequently Asked Questions
Who can join the NCT07767773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Stone Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07767773 currently recruiting?
Yes, NCT07767773 is actively recruiting participants. Contact the research team at abulfotouhahmed@yahoo.com for enrollment information.
Where is the NCT07767773 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07767773 clinical trial?
NCT07767773 is sponsored by Al-Azhar University. The principal investigator is Abul-fotouh Ahmed at Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. The trial plans to enroll 1,200 participants.