European Real-World Registry for Use of the Ion Endoluminal System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-09

Study Completion Date

2029-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to collect collect real-world data for the Ion endoluminal system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures

NCT04612985

CT-guided Minimally Invasive Procedures e.g. Biopsies

WITHDRAWN NA

Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection

NCT02433574

Non-Small-Cell Lung Cancer Carcinoma

UNKNOWN NA

Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

NCT01841060

Malignant Non-small Cell Neoplasm of Lung Stage Ia

COMPLETED NA

LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC

NCT01795521

Non-small Cell Lung Cancer Stage I Non-small Cell Lung Cancer Stage II

UNKNOWN PHASE2

XACT ACE Observational Registry

NCT04950959

Tumors

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Nodule Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observation Group

Subjects with biopsy and/or localization of lung nodule(s)

Ion endoluminal system

Intervention Type DEVICE

Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ion endoluminal system

Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No