Stone Access and Removal (STAR) Study

NCT ID: NCT06330701

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-03-11

Brief Summary

The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.

Conditions

Kidney Calculi

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Robotic mini-Percutaneous Nephrolithotomy (PCNL)

Participants with kidney stones will be enrolled for a robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of kidney stones. The MONARCH Platform, Urology enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible mini-PCNL suction catheter ("catheter") for visualization and access to the urinary tract for diagnostic and therapeutic procedures.

Group Type: EXPERIMENTAL

Robotic-assisted mini-PCNL

Intervention Type: DEVICE

This robotically enabled hybrid procedure called the MONARCH Mini-PCNL will allow the clinician to obtain retrograde and percutaneous access to participant's kidney under continuous visualization for therapeutic applications (i.e., stone removal).

Interventions

Robotic-assisted mini-PCNL

This robotically enabled hybrid procedure called the MONARCH Mini-PCNL will allow the clinician to obtain retrograde and percutaneous access to participant's kidney under continuous visualization for therapeutic applications (i.e., stone removal).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Simple renal caliceal and/or pyelo stone(s) with stone burden => 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines
• Normal upper tract anatomy, amenable to PCNL and ureteroscopy
• Participants with a percutaneous tract length < 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan
• Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment.

Exclusion Criteria

• Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
• Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
• A solitary functioning kidney
• Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
• Presence of ureteral impacted stones

• Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret A. Knoedler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Indiana University

Indianapolis, Indiana, United States

UW School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2023URO0001

Identifier Type: OTHER

Identifier Source: secondary_id

2023URO0001

Identifier Type: -

Identifier Source: org_study_id