Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

Calyxo

Status: Active, not recruiting

Conditions: Renal Stone; Urolithiasis; Kidney Stone

Treatments: Device: SURE; Device: Standard Ureteroscopy (Basketing)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04519294

CP00001

Details and patient eligibility

About

The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for ureteroscopy with laser lithotripsy;
• Presence of renal stone(s);
• Be willing and able to return for all study-related follow up procedures; and,
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion criteria

• BMI > 45;
• Significant comorbidities;
• Bladder, ureteral or kidney abnormalities;
• Pregnant individuals; or
• Unable to meet the treatment and follow up protocol requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

SURE

Active Comparator group

Treatment:

Device: SURE

Standard Ureteroscopy (Basketing)

Active Comparator group

Treatment:

Device: Standard Ureteroscopy (Basketing)