Stone Access and Removal (STAR) Study (NCT06330701) | Clinical Trial Compass
CompletedNot Applicable
Stone Access and Removal (STAR) Study
United States15 participantsStarted 2024-01-18
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure