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Optical versus Digital Flexible Ureteroscopy: a prospective randomized study

New era of Flexible Ureteroscopy: comparison between Digital vs. Optical Flexible Ureteroscope

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9vv3djz
Enrollment
Unknown
Registered
2025-06-13
Start date
2019-02-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Interventions

This is a prospective randomized clinical trial with two parallel groups comparing digital flexible ureteroscope and optical flexible ureteroscope in the treatment of renal and ureteral stones. Partic
E04.950.774.840

Sponsors

Irmandade da Santa Casa de Misericórdia de São Paulo
Lead Sponsor
Irmandade da Santa Casa de Misericórdia de São Paulo
Collaborator

Eligibility

Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: One or more renal stones measuring up to 2cm; one or more stones in the proximal ureter measuring up to 2cm; age over 14 years; both sexes

Exclusion criteria

Exclusion criteria: Malformations that directly or indirectly involve the urinary tract; presence of infectious signs: Leukogram greater than 10 thousand or deviation above 8% band forms, presence of fever in the last 48 hours preceding the procedure

Design outcomes

Primary

MeasureTime frame
The surgical time between procedures performed with optical flexible ureteroscope and digital flexible ureteroscope is expected to be compared. Stone-free rate will also be evaluated using postoperative abdominal and pelvic computed tomography

Secondary

MeasureTime frame
Secondary outcomes include intraoperative parameters such as total volume of saline solution used measured in milliliters, infusion rate of saline solution measured in milliliters per minute, and degree of flexion and deflection of the ureteroscopes before and after the procedures measured in degrees. Procedural safety will also be evaluated

Countries

Brazil

Contacts

Public ContactIso Kauffmann

Irmandade da Santa Casa de Misericórdia de São Paulo

isokauffmann@gmail.com+55-11-21767000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)