CompletedNot applicableNCT01793246

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

StatusCompleted
PhaseNot applicable
U.S. locations9
SponsorMauna Kea Technologies
01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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