NCT07712861

Brief Summary

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.

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
5 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 11, 2026

Last Update Submit

July 11, 2026

Conditions

Kidney StonesUrolithiasisNephrolithiasis

Keywords

kidney stonesmedical deviceUrological procedure

Outcome Measures

Primary Outcomes (3)

  • Procedure success

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

    Intraoperative

  • Serious Adverse Device Effects (SADEs)

    Serious adverse device effects related to the investigational device.

    12 months post-procedure

  • Stone-Free Status

    Absence of residual stone fragments on CT imaging

    30 days post-procedure

Secondary Outcomes (7)

  • Stone-Free Categories

    30 days post-procedure

  • Intrarenal pressure assessment

    Intraoperative

  • Procedure duration

    Intraoperative

  • Stone clearance

    Intraoperative

  • Residual stone burden

    30 days post-procedure

  • +2 more secondary outcomes

Study Arms (1)

Investigational endourological device used during retrograde intrarenal surgery.

EXPERIMENTAL
Device: RIRS with Investigational Device

Interventions

RIRS with Investigational DeviceDEVICE

Investigational endourological device used during retrograde intrarenal surgery.

Investigational endourological device used during retrograde intrarenal surgery.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Alemán

Buenos Aires, Argentina

Location

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Canada

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Muljibhai Patel Urological Hospital

Nadiād, India

Location

Tauranga Urology Research Limited

Tauranga, New Zealand

Location

MeSH Terms

Conditions

Kidney CalculiUrolithiasisNephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Matt Sprinkel

CONTACT

+1 650 465 6200matt@ventarissurgical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2026

First Posted

July 20, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)HK(1)IN(1)NZ(1)AR(1)