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临床试验/NCT07289854
NCT07289854已完成不适用

Portable Endoscopic Camera System Using Modified Action Camera for Endoscopic Sinunasal Examination

University of Arkansas1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年12月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Image Quality Score of Modified Portable Endoscopic Camera System

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Children (Under the age of 18)
  • Patients with over secretory tearing without clinical indication for nasal endoscopy

研究组 & 干预措施

Modified Portable Endoscopic Camera

干预措施: Modified Portable Endoscopic Camera (Device)

结局指标

主要结局

Image Quality Score of Modified Portable Endoscopic Camera System

时间窗: 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.

次要结局

  • Image Quality Score of Standard Endoscopic Tower System(Grading completed within 3 months of enrollment completion.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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