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NCT01033201 · ClinicalTrials.gov registry record
Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 71
- Enrollment target
NCT01033201: Completed study, sponsored by Mayo Clinic.
NCT01033201 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 71 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033201 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 71 participants
- Enrollment target
Study Summary
Lung transplantation is indicated when end-stage lung diseases no longer respond to available standard therapy, making life expectancy short and associated with disability. Acute and chronic rejection are common complications following transplantation, indicating screening bronchoscopies and transbronchial biopsies at three month intervals the first two years, in addition to clinically indicated procedures when rejection or infection is suspected. Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-). BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1 second not explained by acute rejection or infection is used for diagnosis. The new technique of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear level, and these images can be saved and reviewed. This new technology could potentially identify acute and chronic rejection, thus offering and alternative to transbronchial biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection using confocal microscopy images obtained endoscopically, obviating complications of transbronchial biopsies. Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar pathological conditions in real time. Specifically, we hypothesize that confocal endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help to recognize and classify the presence/absence of acute rejection and/or bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also identify the
Interventions
- OTHER Confocal imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01033201
The ClinicalTrials.gov registry entry for NCT01033201 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Confocal imaging is the first listed.
NCT01033201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01033201 about?
NCT01033201 is a clinical study titled "Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo". Lung transplantation is indicated when end-stage lung diseases no longer respond to available standard therapy, making life expectancy short and associated with disability. Acute and chronic rejection are common complications following transplantation, indicating screening bronchoscopies and transbr...
What is the current status of trial NCT01033201?
This trial is currently completed. The enrollment target is 71 participants. The study started on 2008-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01033201?
The interventions under investigation include: Confocal imaging (OTHER).
Who is sponsoring clinical trial NCT01033201?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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