Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
25 participants
INTERVENTIONAL
2022-11-28
2024-09-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exhaled Breath Particles in Lung Cancer
NCT05395611
Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
NCT07042867
Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR-BioMarkers (BM) Profiling)
NCT03493581
Plan for Systematic Identification of Lung Cancers of Occupational Origin: Implementation Study
NCT02696863
Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
NCT02334761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* to evaluate the technical success of the device
* to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence)
* to evaluate the safety of the device
25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Interventional arm
Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
EPIONE device
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EPIONE device
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient with a signed informed consent form.
* Patient covered by a social security system.
Exclusion Criteria
* Pregnant or nursing female, confirmed before the intervention
* Patient already participating in another clinical study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Quantum Surgical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Baptiste BONNET, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gustave Roussy Institut
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QS-IS-G-H-2201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.