ClinicalTrials.gg
Active, not recruitingNCT03256773Updated Jul 8, 2026

High Resolution Micro OCT Imaging

An observational study in Cystic Fibrosis, COPD and PCD - Primary Ciliary Dyskinesia, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by University of Alabama at Birmingham · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
14 Years and older
Sex
All
01

Study summary

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Read the detailed description

Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.

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Conditions studied

  • Cystic Fibrosis
  • COPD
  • PCD - Primary Ciliary Dyskinesia
  • Covid19
  • Sinusitis
  • ILD
  • Normal Controls
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In context

Cystic Fibrosis

1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.

This study's enrollment of 160 is above the median of 85 across 503 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.

Eligibility criteria

THE INCLUSION CRITERIA:

  • Patients diagnosed with CF or healthy normal controls with no respiratory disease
  • Patients must be over the age of 14
  • Patient must be able to give

THE EXCLUSION CRITERIA:

  • Patients with recent respiratory infection requiring antibiotics or in the last 4 weeks (excluding routine perioperative antibiotics)
  • Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares
  • Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room
  • Female subjects who are pregnant
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal

    No lung Disease

  • Cystic Fibrosis

    cystic fibrosis Lung Disease

  • PCD

    Primary Ciliary Dyskinesia

  • COPD

    Chronic Obstructive Lung Disease

  • ILD

    Interstitial Lung Disease

  • COVID-19

    COVID-19 Virus

  • Sinusitis

    Sinusitis

06

What researchers measure

Primary outcomes

  1. feasibility of uOCT probe

    to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients

    Time frame: 1 year

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03256773
Responsible party
Steven M Rowe (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 22, 2017
Start date
Apr 15, 2016
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 8, 2026

Study contacts

Steven M Rowe
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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