Clinical trial NCT04096482: Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses
Official title: Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sinus Problem
Keywords: Nasal endoscopy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: 3NT Medical Ltd.
First posted: 2019-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who have had prior ESS and are scheduled for nasal endoscopy as part of a routine post-operative office visit or due to recurrence of symptoms will be evaluated with the standard endoscope followed by the Peregrine Endoscope.
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: Nasal endoscopy is a minimally invasive, diagnostic medical procedure and currently the most preferred initial method of evaluating medical problems affecting nose and sinuses such as nasal stuffiness and obstruction, sinusitis, nasal polyposis, nasal tumors, epistaxis, recurrent bouts of sneezing and rhinorrhea. Overall, the procedure is considered very safe and low-risk. Currently, nasal endoscopy can be performed with a flexible or rigid endoscope, typically after a topical decongestant and anesthetic are applied to the nasal mucosa.

Reprocessing is an issue of concern, especially for flexible endoscopes where multiple steps were confirmed to be critical for reprocessing to be effective. High-level disinfection has been determined to be the minimum level of disinfection required, which involves multiple steps including manual cleaning, leak testing, cleaning with an enzymatic agent, high-level disinfection, and drying with vertical storage. 3NT Medical Ltd. has developed the Peregrine Drivable Ear Nose and Throat (ENT) Scope, which offers the convenience of a single-use endoscope component coupled with performance characteristics of commercially available state-of-the-art reusable endoscopy systems. The single-use endoscope essentially removes concerns related to burdensome reprocessing techniques of a delicate tool required to achieve high-level of its disinfection.

The objective of this study is to assess the safety and performance of the Peregrine endoscope in patients in the office setting in terms of access and visualization of the paranasal sinus anatomy, image quality, and patient tolerability and pain. For this study, up to 30 patients who have had prior endoscopic sinus surgery (ESS) and who 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 Peregrine Endoscope. Access and visualization by an additional standard endoscope will be conducted and compared to Peregrine endoscope. Image quality of the Peregrine endoscope, participant tolerability and pain, and the impact of Peregrine on clinical decision making will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any medical disorder which in the investigator's judgment contraindicates the patient's participation
* Pregnancy

Primary outcomes:
measure: Number of Participants With Visualization Success of Maxillary Sinus Anatomy
timeFrame: Day 1 (after each endoscopy)
measure: Number of Participants With Visualization Success of Frontal Sinus Anatomy
timeFrame: Day 1 (after each endoscopy)
measure: Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
timeFrame: Day 1 (after each endoscopy)
Secondary outcomes:
measure: Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy
timeFrame: Day 1 (after each endoscopy)
measure: Visual Analogue Scale (VAS) Tolerability Score
timeFrame: Day 1 (after each endoscopy)
measure: VAS Pain Score
timeFrame: Day 1 (after each endoscopy)
measure: Impact on Clinical Workflow
timeFrame: Day 1 (after each endoscopy)
measure: Ease of Use
timeFrame: Day 1 (after each endoscopy)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Joshua Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: