European Real-World Registry for Use of the Ion Endoluminal System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntuitive Surgical
About this trial
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is aged 18 years or older at time of consent.
Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
Patient is willing and able to give written informed consent for clinical study participation.
Disqualifiers
Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
Female patient that is pregnant or breast feeding as determined by standard site practices.
Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
Patient is not willing to comply with post-procedure study participation requirements.
Trial population
Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ion endoluminal system
DeviceLung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
Treatment groups
1,200 Participants
are divided into 1 treatment groupGroup A: Observation Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Intra-procedure through 24 month post-procedureSecondary outcomes
1
Pneumothorax
Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention
Time frame
Intra-procedure through 30 days post-procedure2
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
Time frame
Intra-procedure through the 30 day post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov