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Not yet recruiting NCT07712861

DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis

No phase Interventional Kidney Stones Urolithiasis Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RIRS with Investigational Device.
Who it may be relevant to
Registry conditions: Kidney Stones, Urolithiasis, Nephrolithiasis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina, Canada, Hong Kong, India, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis- A Multicenter Prospective Pilot Study

Overview

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.

Interventions

  • Device RIRS with Investigational Device
    Investigational endourological device used during retrograde intrarenal surgery.

Primary outcome measures

  • Procedure success [Time frame: Intraoperative]
  • Serious Adverse Device Effects (SADEs) [Time frame: 30 days post-procedure]
  • Stone-Free Status [Time frame: 30 days post-procedure]
Secondary outcome measures (7)
  • Stone-Free Categories [Time frame: 30 days post-procedure]
  • Intrarenal pressure assessment [Time frame: Intraoperative]
  • Procedure duration [Time frame: Intraoperative]
  • Stone clearance [Time frame: Intraoperative]
  • Residual stone burden [Time frame: 30 days post-procedure]
  • Device- or procedure-related adverse event [Time frame: From procedure to 12 months post-procedure]
  • Stone-related healthcare utilization [Time frame: From procedure to 12 months post-procedure]

Eligibility criteria

Inclusion criteria

  • 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
  • Signs study-specific informed consent form

Exclusion criteria

  • 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
  • Urological anatomic/congenital abnormalities
  • Previous history of struvite stone in the same renal unit
  • Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
  • History of gross hematuria
  • Solitary functioning kidney
  • Known allergy to device materials
  • Any severe illness that would prevent complete study participation or confound study results
  • Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure - NYHA Class IV), pulmonary disease or uncontrolled diabetes.
  • History of open-heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
  • ASA III or higher
  • Taking systemic immune suppressants
  • Dementia or psychiatric condition that prevents the participant from completing required follow up
  • Contraindication to both general and spinal anesthesia
  • Participating in another investigational study that could affect responses to the study device
  • Unwilling to accept a transfusion should one be required
  • Pregnant or considering getting pregnant within the next 3 months
  • Undergoing bilateral ureteroscopy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Argentina · 1 center
  • Hospital Alemán — Buenos Aires
Canada · 1 center
  • Centre hospitalier de l'Universite de Montreal (CHUM) — Montreal
Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong
India · 1 center
  • Muljibhai Patel Urological Hospital — Nadiād
New Zealand · 1 center
  • Tauranga Urology Research Limited — Tauranga

Identifiers

NCT: NCT07712861 · VS-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗