Health TrialsbyHealthPanel

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

ConditionsKidney StonesUrolithiasisNephrolithiasis
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • RIRS with Investigational Device

    Device

    Investigational endourological device used during retrograde intrarenal surgery.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Investigational endourological device used during retrograde intrarenal surgery.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procedure success

Successful completion of the planned procedure without device-related technical complications.

Time frame
Intraoperative
2

Serious Adverse Device Effects (SADEs)

Serious adverse device effects related to the investigational device.

Time frame
30 days post-procedure
3

Stone-Free Status

Absence of residual stone fragments on CT imaging

Time frame
30 days post-procedure

Secondary outcomes

1

Stone-Free Categories

Stone-free status according to predefined categories.

Time frame
30 days post-procedure
2

Intrarenal pressure assessment

Intrarenal pressure measured during the procedure.

Time frame
Intraoperative
3

Procedure duration

Duration of the surgical procedure.

Time frame
Intraoperative
4

Stone clearance

Amount of stone material removed during the procedure.

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ventaris Surgical Incorporated

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: