NCT01793246

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

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Mauna Kea Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.

Conditions

• Lung Neoplasms
• Disorder Related to Lung Transplantation

Interventions

Type	Name	Description
DEVICE	probe based laser endomicroscopy (pCLE)	pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-24
• Completion: 2016-12-24
• First posted: 2013-02-15
• Last updated: 2017-08-29

Locations

9 sites across 1 country: United States