Lung Diseases Clinical Trial
Official title:
Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System
This study is designed to provide clinical data regarding safety and clinical effectiveness of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous needle biopsy or aspiration of pulmonary lesions, which is a common procedure.
This will be a prospective, single-arm study. At least three centers in Canada will
participate in the study and at least 4 different experienced staff radiologists will
perform the procedures for the study.
A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled
for clinically indicated CT guided lung biopsy or aspiration procedure at the participating
centers will be invited to enroll in the study. To ensure diversity in the study population,
consecutive patients will be enrolled in the following groups until these groups are fully
enrolled:
Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size >1.5 and ≤ 3.0 cm: 19 patients;
Lesion size >3.0 cm: 19 patients.
A maximum of 24 patients will be enrolled at each center.
Informed consent will be signed prior to the procedure. Subject data collection on the day
of the procedure will include demographics, relevant medical history and vital signs.
Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as
clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance
System. Subjects will be followed-up as outlined below to assess adverse events related to
the procedure. A subject's enrollment in the study will be completed after the follow-up
visit or after resolution of any procedure related adverse event.
A procedure difficulty classification is defined for this study, based on existing
literature. Difficulty levels for all procedures will be recorded and included in the final
report.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
| Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
| Terminated |
NCT03309358 -
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
|
Phase 1 | |
| Completed |
NCT03682354 -
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
|
N/A | |
| Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
| Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
| Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
| Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
| Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01443845 -
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
|
Phase 4 | |
| Completed |
NCT00281216 -
Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
|
N/A | |
| Completed |
NCT00269256 -
Stress, Environment, and Genetics in Urban Children With Asthma
|
N/A | |
| Terminated |
NCT00233207 -
IC14 Antibodies to Treat Individuals With Acute Lung Injury
|
Phase 2 | |
| Recruiting |
NCT00129350 -
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
|
Phase 1 | |
| Active, not recruiting |
NCT00115297 -
Montelukast for Early Life Wheezing
|
Phase 2/Phase 3 | |
| Completed |
NCT00094276 -
Intervention for Improving Asthma Care for Minority Children in Head Start
|
N/A | |
| Completed |
NCT00091767 -
Genetic Studies in Difficult to Treat Asthma: TENOR
|
N/A | |
| Completed |
NCT00089752 -
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT00069823 -
Study of Acid Reflux in Asthma
|
Phase 3 | |
| Completed |
NCT00233168 -
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
|
N/A |