Clinical trial NCT05835323: Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones
Official title: Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Keywords: Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect descriptive performance data using the MONARCH Platform, Urology (a novel robotic device) to perform mini-percutaneous nephrolithotomy (kidney stone removal) procedures. Data gathered from this study will be used to optimize the robotic platform and inform training and education material for the future users.


Eligibility criteria: Inclusion Criteria:

* Simple renal caliceal and/or pyelo stone(s), greater than or equal to (\>=) 10 millimeter in size identified on computerized tomography (CT) scan, and appropriate for Percutaneous nephrolithotomy (PCNL) treatment according to American Urological Association (AUA) guidelines
* Normal upper tract anatomy, amenable to PCNL and ureteroscopy
* Body mass index less than (\<) 40 kilogram-meter squared
* Participants with a percutaneous tract length \<15 centimeter 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

Pre-Operative Exclusion Criteria:

* Any medical or physical condition/limitation that would contraindicate a conventional ureteroscopy or PCNL \[for example, atypical interposition of visceral organs (bowel, spleen, or liver)\] in the supine position. This assessment will be made by the investigator team
* Participation in any other clinical trial 30-days before and throughout the duration of the study that might impact the results
* A solitary functioning kidney
* Female subjects who are pregnant or nursing or those of childbearing potential refusing a pregnancy test
* Presence of ureteral impacted stones
* Presence of ureteral obstruction
* Presence of untreated urinary tract infection, urosepsis
* Inability to give consent
* Presence of a renal mass which has not been investigated
* Staghorn stone
* Participant has an electrically or magnetically activated implanted medical device
* Significant pharmacological anticoagulant therapy or uncorrected bleeding diathesis
* Tumor in the probable access tract area and potential malignant renal tumor

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. For example, participants no longer considered good candidates for a mini-PCNL procedure for the removal of the kidney stones.

Primary outcomes:
measure: Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
timeFrame: Day of Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California - Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Jaime Landman, MD
role: PRINCIPAL_INVESTIGATOR
References: