Trials / Completed
CompletedNCT05835323
Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones
Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Auris Health, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic-assisted mini-PCNL | Eligible participants will be enrolled to undergo robotic-assisted PCNL using the MONARCH Platform, Urology for the removal of kidney stones. The MONARCH Platform, Urology is a novel flexible robotic device that enables the clinician to obtain both transurethral and percutaneous access to a participant's kidney under continuous visualization for therapeutic application (for example, stone removal). |
Timeline
- Start date
- 2023-01-11
- Primary completion
- 2023-09-25
- Completion
- 2023-11-01
- First posted
- 2023-04-28
- Last updated
- 2025-07-08
- Results posted
- 2024-10-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05835323. Inclusion in this directory is not an endorsement.