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CompletedNot applicableNCT01793246
Official study title

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung

Study summary

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedprobe based laser endomicroscopy (pCLE)

The study team can explain what participation involves.

Who it may be forLung Neoplasms · Disorder Related to Lung Transplantation

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 29, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Mauna Kea Technologies

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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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