Stone Access and Removal (STAR) Study

Kidney Calculi Clinical Trial

— STAR  

Official title:

Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330701
• Other study ID #: 2023URO0001
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Auris Health, Inc.
• Contact: Study L. Contact, Ph.D.
• Phone: 609-937-6963
• Email: nsehgel[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana
United States	UW School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed	The percentage of Robotic-assisted mini-PCNL procedures that are successfully completed will be reported. Completion is defined as: (1) gained safe concomitant (that is, retrograde and antegrade) access to the upper urinary tract, (2) located and visualized kidney stones, (3) enabled fragmentation of stones by standard of care method (4) evacuated stone fragments and dust, and (5) Complete treatment without need for case conversion, as assessed by the investigator.	Procedure Visit (Day 0)
Secondary	Stone Free Rate (%)	Stone free is defined as having <= 4mm residual stones detected by computed tomography (CT), assessed at post-operative Day 30.	Post-operative Day 30
Secondary	Number of Adverse Events	Adverse events are defined as any undesirable clinical occurrence in a participant, whether or not it is considered to be device-related.	Up to post-operative Day 90
Secondary	Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event	Number of procedures converted to conventional stone removal procedures (e.g., ureteroscopy or percutaneous nephrolithotomy) due to the occurrence of a study device-related safety event.	Procedure Visit, Day 0