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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735341
Enrollment
30
Registered
2021-02-03
Start date
2020-12-09
Completion date
2022-06-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Pulmonary Nodule, Solitary

Brief summary

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

Interventions

Ion Endoluminal Procedure for pulmonary nodule

Sponsors

Intuitive Surgical
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Ion Catheter ShapeIntra-operativeThe collection of data relating to the Ion catheter shape

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026