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| ID | Type | Description | Link |
|---|---|---|---|
| 2023URO0001 | Other Identifier | Auris Health,Inc. |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic mini-Percutaneous Nephrolithotomy (PCNL) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure | 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. | On the day of procedure at Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Free Rate | 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. | Post-operative Day 30 |
| Number of Participants With Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
Pre-Procedure:Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Margaret A. Knoedler, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| UW School of Medicine and Public Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Assisted Combined Intrarenal Surgery (RACIRS) | Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Assisted Combined Intrarenal Surgery (RACIRS) | Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure | 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. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Posted | Number | percentage of participants | On the day of procedure at Day 1 |
|
All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic Assisted Combined Intrarenal Surgery (RACIRS) | Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dir Clin Dev NonMD | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2023 | Dec 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2025 | Dec 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
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. |
| From the day of procedure (Day 1) up to 90 days post-procedure |
| Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event | 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. | On the day of procedure (Day 1) |
| Madison |
| Wisconsin |
| 53705 |
| United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants With Stone | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Count of Participants | Participants |
|
| Participant-Level Pre-operative Linear Stone Burden | Cumulative stone burden for each participant was calculated by summing the longest dimension of each stone within a participant, and then summarizing across all participants. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Mean | Standard Deviation | Millimeters (mm) |
|
| Participant-Level Pre-operative Stone Volume | Cumulative stone volume for each participant was calculated by first determining the volume of each stone as (Pi/6) * x dimension * y dimension * z dimension, then summing across all stones within a participant, and then summarizing across all participants. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Mean | Standard Deviation | Millimeter cube (mm^3) |
|
| Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. |
|
|
| Secondary | Stone Free Rate | 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. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome. | Posted | Number | 95% Confidence Interval | percentage of participants | Post-operative Day 30 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | 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. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Posted | Count of Participants | Participants | From the day of procedure (Day 1) up to 90 days post-procedure |
|
|
|
| Secondary | Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event | 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. | Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. | Posted | Number | percentage of participants | On the day of procedure (Day 1) |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 13 |
| 15 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Penile discomfort | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Prior to submission by a Principal Investigator for publication or presentation, the Sponsor will be provided with the opportunity to review the submission for confidential information and accuracy.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|
| Grade IV |
|
| Grade V |
|