DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVentaris Surgical Incorporated
About this trial
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
Eligibility criteria
Qualifiers
Diagnosis of calyceal and/or renal pelvis calculi
Age from 18 through 85 years
Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment
Willing and able to comply with all study requirements
Disqualifiers
Diagnosis of calculus of the ureter
BMI ≥ 42
Significant renal impairment: stage 3a CKD or higher (eGFR <59mL/min)
Active infection, including urinary tract infection
Trial design
Treatments tested in this trial
- RIRS with Investigational Device
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov