Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses
Stopped early · Not applicable
Conditions studied: Sinus Problem
In brief
The purpose of this study is to assess the safety and effectiveness of the Peregrine endoscope in patients in the office setting in terms of access into and visualization of the paranasal sinus anatomy, image quality, patient tolerability and clinical utility. Up to 30 participants who have had prior endoscopic sinus surgery (ESS) and are scheduled for nasal endoscopy in the office as part of a routine post-operative office visit or due to recurrence of symptoms, will be evaluated with the Peregrine Endoscope as well as a standard endoscope. This study aims to: * compare visualization success rates of the paranasal sinus anatomy by Peregrine and by a standard endoscope used in the office setting. * examine device related adverse events. * assess the adequacy of the image quality of Peregrine for endoscopy procedures in the office. * evaluate patient tolerability and pain
Key facts
- Study ID
- NCT04096482
- Run by
- Emory University
- People needed
- 6
- Starts
- 2019-11-05
- Expected to finish
- 2020-09-01
- Last updated by the study team
- 2021-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A male or female patient who has had prior ESS and who is indicated for office endoscopy by the ENT specialist
- A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent form
You may not qualify if…
- Any medical disorder which in the investigator's judgment contraindicates the patient's participation
- Pregnancy
Where it is running
- Emory Hospital Midtown — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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