MedDataX Logo

High Resolution Micro OCT Imaging

NCT ID: NCT03256773

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis COPD PCD - Primary Ciliary Dyskinesia Covid19 Sinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Notmal

No lung Disease

No interventions assigned to this group

Cystic Fibrosis

cystic fibrosis Lung Disease

No interventions assigned to this group

PCD

Primary Ciliary Dyskinesia

No interventions assigned to this group

COPD

Chronic Obstructive Lung Disease

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 informed consent

Exclusion Criteria

* Patients with recent respiratory infection requiring antibiotics or corticosteroids 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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven M Rowe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven M Rowe

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01HL116213

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F160125001

Identifier Type: -

Identifier Source: org_study_id