NCT05835323 is a NA clinical trial of Robotic-assisted mini-PCNL in Kidney Calculi, sponsored by Auris Health, Inc..

Who is sponsoring NCT05835323?

NCT05835323 is sponsored by Auris Health, Inc..

What drugs are being tested in NCT05835323?

Interventions in NCT05835323: Robotic-assisted mini-PCNL.

What condition does NCT05835323 study?

NCT05835323 studies Kidney Calculi.

Is NCT05835323 still recruiting?

NCT05835323 is currently completed. Last updated 8 July 2025.

Are results published for NCT05835323?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-08 · How we verify

NCT05835323

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones

Completed NA Results posted Last updated 8 July 2025

What this trial tests

NA trial testing Robotic-assisted mini-PCNL in Kidney Calculi in 15 participants. Completed in 1 November 2023.

Timeline

11 January 2023

Primary endpoint
25 September 2023

1 November 2023

Quick facts

Lead sponsor	Auris Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	11 January 2023
Primary completion	25 September 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

Robotic-assisted mini-PCNL

Conditions studied

Kidney Calculi — all drugs for Kidney Calculi →

Sponsor

Auris Health, Inc.

Who can join

22 and older, any sex, with Kidney Calculi. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure. Primary · Day of Procedure

Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.

Group	Value	95% CI
Robotic Mini-PCNL	12

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days post stone removal procedure. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Robotic Mini-PCNL

Serious: 1/13 (8%)

Deaths: 0/13

Serious adverse events (1 terms)

Reaction	System	Robotic Mini-PCNL
Bacteraemia	Infections and infestations	—

Other adverse events (2 terms — click to expand)

Reaction	System	Robotic Mini-PCNL
Urinary tract infection	Infections and infestations	—
Ureteric injury	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Bacteraemia.

Data from ClinicalTrials.gov NCT05835323 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Robotic-assisted mini-PCNL

Trials testing the same drug.

NCT06330701 — Stone Access and Removal (STAR) Study · NA · completed

Other recruiting trials for Kidney Calculi

Currently open trials in the same condition.

NCT06989320 — Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease · NA · recruiting
NCT06667557 — Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy · recruiting
NCT07238803 — Outcomes of Using FANS With FURS in TTT of Lower Calyceal Stones. · NA · recruiting
NCT06684756 — Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery · NA · active not recruiting
NCT06331546 — Gut Oxalate Absorption in Calcium Oxalate Stone Disease · NA · recruiting

Other Auris Health, Inc. trials

Trials by the same sponsor.

NCT06330701 — Stone Access and Removal (STAR) Study · NA · completed
NCT05426213 — A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions · NA · withdrawn
NCT04182815 — Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung · completed
NCT03727425 — Robotic Bronchoscopy for Peripheral Pulmonary Lesions · NA · completed
NCT03497026 — Auris Robotic Endoscopy System for Bronchoscopy · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05835323 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Auris Health, Inc.
Last refreshed: 8 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05835323.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing