Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses

Not Applicable

Terminated

• Conditions: Sinus Problem
• Interventions: Device: Peregrine Drivable ENT Scope; Device: Standard 30° 4mm Endoscope

• Registration Number: NCT04096482
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2019-11-05
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Results First Submitted: 2021-08-24
• Results First Submitted QC: 2021-08-24
• Status Verified: 2021-09
• Results First Posted: 2021-09-20
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard 30° 4mm Endoscope Followed by Peregrine Endoscope	Peregrine Drivable ENT Scope	Participants will receive an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.
Standard 30° 4mm Endoscope Followed by Peregrine Endoscope	Standard 30° 4mm Endoscope	Participants will receive an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Visualization Success of Frontal Sinus Anatomy	Day 1 (after each endoscopy)	The ability of each endoscope type to visualize the frontal sinus anatomy (ostium, posterior table, anterior table, lateral recess) was assessed as being a success or failure.
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy	Day 1 (after each endoscopy)	The ability of each endoscope type to visualize the sphenoid sinus anatomy (ostium, sella, floor, lateral aspect) was assessed as being a success or failure.
Number of Participants With Visualization Success of Maxillary Sinus Anatomy	Day 1 (after each endoscopy)	The ability of each endoscope type to visualize the maxillary sinus anatomy (ostium, floor, lateral recess, anterior wall) was assessed as being a success or failure.

Secondary Outcome Measures

Name	Time	Method
VAS Pain Score	Day 1 (after each endoscopy)	Participant pain was evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = no pain and 10 = pain as bad as it could be.
Ease of Use	Day 1 (after each endoscopy)	The ease of use of each endoscope procedure was rated by physicians on a 5-point scale where 1 = worst and 5 = best.
Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy	Day 1 (after each endoscopy)	Image quality will be assessed through a yes/no statement, reported by physicians, regarding the adequacy of the Peregrine image quality for making clinical decisions in the office setting.
Impact on Clinical Workflow	Day 1 (after each endoscopy)	The impact on clinical workflow of visual information obtained by each endoscope procedures was rated by physicians on a 5-point scale where 1 = worst and 5 = best.
Visual Analogue Scale (VAS) Tolerability Score	Day 1 (after each endoscopy)	Participant tolerability was evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = highly tolerable and 10 = not tolerable.

Trial Locations

Locations (1)

Emory Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States