Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.
Checked against the public recordLast updated Aug 29, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Mauna Kea Technologies
- Interventions being studied
- Device: probe based laser endomicroscopy (pCLE)
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: * Male or female \> 18 years of age * Willing and able to comply with study procedures and provide written informed consent to participate in the study * Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy * Newly discovered \&/or prior discovered non classified nodules, hard to define based on CT scan * Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions * All lesion locations are acceptable * Any patient undergoing clinically indicated bronchoscopies after lung transplantation * Patients post transplant showing clinical signs of acute rejection \>3 weeks; \< 1 year * Patient with single or double lung transplant Exclusion Criteria: * Contraindication to short-acting anesthetic agents; * Contraindications to transbronchial biopsy * Bleeding diathesis; * A pacemaker/defibrillator; * A diagnosis by other means (sputum cytology, microbiology). * Unwilling To Consent * Unable To Safely Tolerate A Bronchoscopic Procedure * Unwilling To Comply With Surveillance Bronchoscopy Follow Up * Chronic Rejection * Fungal Disease * Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- St. Joseph's Medical CenterPhoenix, Arizona
- Mayo ClinicJacksonville, Florida
- University of ChicagoChicago, Illinois
- Columbus Regional HospitalColumbus, Indiana
- University of Louisiana ShreveportShreveport, Louisiana
- Walter Reed Military Medical CenterBethesda, Maryland
- University of MichiganAnn Arbor, Michigan
- University of RochesterRochester, New York
- Ohio State UniversityColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 29, 2017. Always confirm current availability with the study team.