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NCT04735341 Clinical Trial

Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

Lung Cancer Clinical Trial

Official title:
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04735341
Other study ID # ISI-IonLR-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 9, 2020
Est. completion date June 30, 2022

Study information
Verified date August 2022
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ion Endoluminal System
Ion Endoluminal Procedure for pulmonary nodule

Locations
Country Name City State
United States FirstHealth of the Carolinas Moore Regional Hospital Pinehurst North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ion Catheter Shape The collection of data relating to the Ion catheter shape Intra-operative
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