- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289854
Portable Endoscopic Camera System Using Modified Action Camera for Endoscopic Sinunasal Examination
This study is designed to compare two methods for performing a nasal endoscopic examination used in the evaluation of excessive watering or tearing of the eyes. The purpose of the study is to determine whether a new, smaller, modified camera system can produce images of the inside of the nose that are as clear and useful as those produced by the standard endoscopic camera system currently used in clinics.
The study seeks to answer the question of whether a compact, easy-to-store camera system can provide similar diagnostic image quality to the traditional, larger tower-based system. The clinical steps of the nasal examination remain the same; the only difference is the type of camera system used to capture the images.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study evaluates two imaging systems used during routine nasal endoscopy performed for assessment of epiphora and related nasolacrimal or sinonasal concerns. The protocol involves conducting a standard nasal endoscopic examination with the conventional full-size tower-mounted camera system typically utilized in ophthalmology and otolaryngology outpatient settings, followed by a second examination using a modified compact camera system. Both examinations use the same endoscope and follow identical clinical steps.
The modified camera system attaches at the usual hand-position point on the endoscope and is designed to reduce equipment footprint, increase portability, and simplify storage. The second examination adds an estimated 3-5 minutes to the clinical encounter and does not introduce additional maneuvers or diagnostic procedures.
The primary objective is to compare image quality between the standard system and the compact system. Secondary objectives include assessments of device usability, handling characteristics, and overall feasibility of integrating the compact system into routine clinical workflow.
This evaluation aims to determine whether the compact camera system can provide imaging performance comparable to the traditional tower-based system while offering potential operational benefits. These benefits may include improved flexibility in space-constrained environments, reduced dependence on fixed equipment, and expanded opportunities for nasal endoscopy in clinics with limited infrastructure. Findings may inform future decisions regarding endoscopic equipment selection across various clinical settings.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Adult patients (≥ 18 years old) undergoing a clinically indicated nasal endoscopic examination
- Patients may include, but are not limited to, those presenting with tearing suggestive of nasolacrimal drainage obstruction or sinonasal disease
Exclusion Criteria
- Children (Under the age of 18)
- Patients with over secretory tearing without clinical indication for nasal endoscopy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Modified Portable Endoscopic Camera
|
The Sony Action Camera was modified to allow direct coupling with a standard rigid nasal endoscope:
The modified system captures both video and still images. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image Quality Score of Modified Portable Endoscopic Camera System
Time Frame: Grading completed within 3 months of enrollment completion.
|
Image quality of the modified portable endoscopic camera system will be evaluated using a 5-point Likert scale assessing resolution, clarity of anatomical structures, and overall clinical utility.
Three attending physicians will independently grade anonymized images from each nasal anatomical site.
Scores will be compared with those obtained from the standard endoscopic tower.
|
Grading completed within 3 months of enrollment completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image Quality Score of Standard Endoscopic Tower System
Time Frame: Grading completed within 3 months of enrollment completion.
|
Image quality of the standard endoscopic tower will be evaluated using the same 5-point Likert grading scale and process applied to the modified system.
These scores will serve as the comparator for paired analysis.
|
Grading completed within 3 months of enrollment completion.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omar Solyman, MD, University Of Arkansas For Medical Sciences, Jones Eye Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 299385
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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