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The objective of this study is to collect collect real-world data for the Ion endoluminal system.
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group | Subjects with biopsy and/or localization of lung nodule(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ion endoluminal system | Device | Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield | Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only. | Intra-procedure through 24 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax | Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention | Intra-procedure through 30 days post-procedure |
| Bleeding | Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jana Meschede | Contact | +41 21 821 2000 | IonEURegistry@intusurg.com | |
| Martha Bean | Contact | +41 21 821 2000 | IonEURegistry@intusurg.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Intra-procedure through the 30 day post-procedure |
| Helios Klinikum Emil von Behring | Recruiting | Berlin | 14165 | Germany |
|
| Helios Dr. Horst Schmidt Kliniken | Not yet recruiting | Wiesbaden | 65199 | Germany |
|
| Universitätsspital Zürich | Recruiting | Zurich | 8091 | Switzerland |
|
| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW1 2BU | United Kingdom |
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| Wythenshawe Hospital, Manchester University NHS Foundation Trust | Recruiting | Manchester | M23 9LT | United Kingdom |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |