Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease
To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.
Checked against the public recordLast updated Mar 12, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Lahey Clinic
- Interventions being studied
- Device: Optical Frequency Domain Imaging (OFDI) System
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the central airways * Patients must be over the age of 18 * Patient must be able to give informed consent * Women with child bearing potential must have a negative pregnancy test within seven days prior to the procedure Exclusion Criteria: * PaO2 less than 80 on FiO2 greater 70% * Systolic blood pressure less than 90 * Active bronchospasm * INR greater than 2.0 (INR: International Normalized Ratio) * Recent myocardial infarction within last two weeks * Active cardiac chest pain * Significant untreated sleep apnea * FEV1 less than 30% of predicted (FEV1: forced expiratory volume in 1 second) * Worsening hypercarbia with PaCO2 greater than 55 * In active respiratory failure (unless endotracheal intubation is performed first to stabilize the airway)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Lahey Clinic, Inc.Burlington, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2019. Always confirm current availability with the study team.