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

July 11, 2026 updated by: Ventaris Surgical Incorporated

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of calyceal and/or renal pelvis calculi
  2. Age from 18 through 85 years
  3. 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
  4. Willing and able to comply with all study requirements
  5. Signs study-specific informed consent form

Exclusion Criteria:

  1. Diagnosis of calculus of the ureter
  2. BMI ≥ 42
  3. Significant renal impairment: stage 3a CKD or higher (eGFR <59mL/min)
  4. Active infection, including urinary tract infection
  5. Urological anatomic/congenital abnormalities
  6. Previous history of struvite stone in the same renal unit
  7. Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
  8. History of gross hematuria
  9. Solitary functioning kidney
  10. Known allergy to device materials
  11. Any severe illness that would prevent complete study participation or confound study results
  12. 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.
  13. History of open-heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
  14. ASA III or higher
  15. Taking systemic immune suppressants
  16. Dementia or psychiatric condition that prevents the participant from completing required follow up
  17. Contraindication to both general and spinal anesthesia
  18. Participating in another investigational study that could affect responses to the study device
  19. Unwilling to accept a transfusion should one be required
  20. Pregnant or considering getting pregnant within the next 3 months
  21. Undergoing bilateral ureteroscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational endourological device used during retrograde intrarenal surgery.
Device: RIRS with Investigational Device
Investigational endourological device used during retrograde intrarenal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure success
Time Frame: Intraoperative
Successful completion of the planned procedure without device-related technical complications.
Intraoperative
Serious Adverse Device Effects (SADEs)
Time Frame: 12 months post-procedure
Serious adverse device effects related to the investigational device.
12 months post-procedure
Stone-Free Status
Time Frame: 30 days post-procedure
Absence of residual stone fragments on CT imaging
30 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-Free Categories
Time Frame: 30 days post-procedure
Stone-free status according to predefined categories.
30 days post-procedure
Intrarenal pressure assessment
Time Frame: Intraoperative
Intrarenal pressure measured during the procedure.
Intraoperative
Procedure duration
Time Frame: Intraoperative
Duration of the surgical procedure.
Intraoperative
Stone clearance
Time Frame: Intraoperative
Amount of stone material removed during the procedure.
Intraoperative
Residual stone burden
Time Frame: 30 days post-procedure
Residual stone burden assessed by imaging.
30 days post-procedure
Device- or procedure-related adverse event
Time Frame: From procedure to 12 months post-procedure
Device- or procedure-related adverse event.
From procedure to 12 months post-procedure
Stone-related healthcare utilization
Time Frame: From procedure to 12 months post-procedure
Healthcare utilization related to recurrent stone symptoms in the treated kidney.
From procedure to 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ventaris Surgical Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VS-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because this is an early feasibility study involving a small cohort of participants. The data set is limited and may contain information that could risk re-identification. Summary results and aggregate findings will be published following study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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