Trials / Unknown
UnknownNCT03893539
Clinical Utility for Ion Endoluminal System
PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 365 (actual)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ion Endoluminal System™ | The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. |
Timeline
- Start date
- 2019-03-29
- Primary completion
- 2022-05-26
- Completion
- 2024-05-01
- First posted
- 2019-03-28
- Last updated
- 2024-03-29
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03893539. Inclusion in this directory is not an endorsement.