Trials / Completed
CompletedNCT05093127
CArotid Robotic Procedure Evaluation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Robocath · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the use of R-One in the peripheral vasculature.
Detailed description
This is a prospective, single-arm, monocenter study to evaluate the R-one use in carotid artery stenting procedures. Up to 8 patients will be included and followed at 30 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Carotid Artery Stenting | R-OneTM system is a tool available to physicians for performing CAS without changing the treatment of the pathology. R-OneTM system is designed to remotely deliver and manipulate guidewires and stent/balloon devices during Carotid Artery Stenting. The system is composed of the R-OneTM robotic platform used in combination with two accessories, the Mobile radioprotection screen and a sterile and single-use R-OneTM consumable kit. The physician, seated at the remote radio-protected control station, manipulates guidewires and/or balloon/stent catheters using joysticks on the Command unit. |
Timeline
- Start date
- 2021-11-16
- Primary completion
- 2022-11-15
- Completion
- 2022-11-15
- First posted
- 2021-10-26
- Last updated
- 2023-05-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05093127. Inclusion in this directory is not an endorsement.