Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
Sponsor
Intuitive Surgical (Industry)
Overall Status
Completed
CT.gov ID
NCT04735341
Collaborator
(none)
30
1
18.7
1.6
Study Details
Study Description
Brief Summary
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
Actual Study Start Date
:
Dec 9, 2020
Actual Primary Completion Date
:
Jun 30, 2022
Actual Study Completion Date
:
Jun 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects with planned Ion Endoluminal Procedure with pulmonary nodule
|
Device: Ion Endoluminal System
Ion Endoluminal Procedure for pulmonary nodule
|
Outcome Measures
Primary Outcome Measures
- Ion Catheter Shape [Intra-operative]
The collection of data relating to the Ion catheter shape
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Age of 18 years or older
-
Undergoing a lung biopsy procedure with Ion System
-
Have peripheral pulmonary lesion (5th bronchial generation or higher)
-
Willingness to participate as demonstrated by signing the informed consent
Exclusion Criteria:
-
Unable to provide informed consent
-
Presence of bilateral nodules intended to be biopsied during procedure
-
The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
-
Vulnerable population (e.g., prisoners, mentally disabled)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FirstHealth of the Carolinas Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT04735341
Other Study ID Numbers:
- ISI-IonLR-001
First Posted:
Feb 3, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: