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Completed

NCT Number: NCT06330701

Stone Access and Removal (STAR) Study

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic-assisted mini-PCNL

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).

Primary outcomes

  1. Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure

    Time frame: On the day of procedure at Day 1

    Percentage of participants who achieved successful completion of the RACIRS kidney stone removal procedure were reported. Successful completion of the robotic-assisted kidney stone removal procedure was defined as using robotic-assistance provided by the MONARCH Platform, Urology to achieve the following procedure milestones: (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) completed treatment without need for case conversion, as assessed by the investigator.

Secondary outcomes

  1. Stone Free Rate

    Time frame: Post-operative Day 30

    Stone free rate was computed as the percentage of participants who were stone free assessed by computed tomography (CT) scan at post-operative Day 30. Stone free was defined as having less than or equal to (<=) 4 millimeters (mm) residual stones detected by CT.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: From the day of procedure (Day 1) up to 90 days post-procedure

    AEs were defined as any undesirable clinical occurrence in a participant, whether or not it is considered to be device-related. Adverse events were graded using the Clavien-Dindo classification system. Clavien-Dindo consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population. Grade I to II included deviations from normal recovery requiring minimal or pharmacologic treatment. Grade III to IV involved surgical/endoscopic/radiologic interventions or life-threatening complications, with subgrades based on anesthesia and organ dysfunction. Grade V represented death of the participant.

  3. Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event

    Time frame: On the day of procedure (Day 1)

    Percentage of participants with procedures converted to conventional stone removal procedures (for example, ureteroscopy or percutaneous nephrolithotomy) due to the occurrence of a study device-related safety event was reported. A qualifying safety event was a study device-related adverse event that occurred during the study procedure, which prompted the physician to abort the study procedure, and pursue a conventional stone removal procedure.

Sponsors and collaborators

Lead sponsor

Auris Health, Inc.

Industry

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 26, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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