NCT03893539
Active, Not Recruiting
N/A
PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pulmonary Nodule
- Sponsor
- Intuitive Surgical
- Enrollment
- 365
- Locations
- 6
- Primary Endpoint
- Navigation Success
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 years and older
- •Patient is suitable for elective bronchoscopy
- •Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
- •Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension
- •Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus\*
- •Patients are candidates for CT-guided needle biopsy and/or surgical resection
- •Patient able to understand and adhere to study requirements
- •Patient able to understand and adhere to study requirements and able to provide informed consent
- •Patient not legally incapacitated or in legal/court ordered institution
- •Patients with no dependency on the investigator or sponsor
Exclusion Criteria
- •Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
- •Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
- •Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
- •Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e.\> 30 breaths per minute) per physician assessment)
- •Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
- •World Health Organization functional Class III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
- •Lung abscess
- •Known or suspected pregnancy
- •Recent head injury (\<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
- •Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)
Outcomes
Primary Outcomes
Navigation Success
Time Frame: Day 1 (Time of Procedure)
Biopsy Success
Time Frame: Day 1 (Time of Procedure)
Sensitivity for Malignancy of System-Obtained Sample
Time Frame: 14 months Post-Procedure
Secondary Outcomes
- Complications(Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure)
Study Sites (6)
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