Stone Access and Removal (STAR) Study

Auris Health

Status: Enrolling

Conditions: Kidney Calculi

Treatments: Device: Robotic-assisted mini-PCNL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06330701

2023URO0001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Pre-Procedure: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

Intra-Procedure Exclusion Criteria:

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Robotic mini-Percutaneous Nephrolithotomy (PCNL)

Experimental group

Description:

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.

Treatment:

Device: Robotic-assisted mini-PCNL