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

NCT ID: NCT04096482

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2020-09-01

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.

Conditions

Sinus Problem

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard 30° 4mm Endoscope Followed by Peregrine Endoscope

Participants will receive an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.

Group Type: EXPERIMENTAL

Peregrine Drivable ENT Scope

Intervention Type: DEVICE

Peregrine, developed by 3NT Medical, is a single-use disposable handheld endoscope, which is thinner and more flexible than other endoscopes. The endoscope includes a camera at its end and a working channel. The thin endoscope provides a means to visualize the nasal cavity and paranasal sinus space and to deliver irrigation to treat the sinus ostia (drainage openings) and spaces within the paranasal sinus cavities

Standard 30° 4mm Endoscope

Intervention Type: DEVICE

The Standard 30° 4mm endoscopic sinus evaluation is the standard procedure that would normally be used to evaluate the condition of each participant.

Interventions

Peregrine Drivable ENT Scope

Peregrine, developed by 3NT Medical, is a single-use disposable handheld endoscope, which is thinner and more flexible than other endoscopes. The endoscope includes a camera at its end and a working channel. The thin endoscope provides a means to visualize the nasal cavity and paranasal sinus space and to deliver irrigation to treat the sinus ostia (drainage openings) and spaces within the paranasal sinus cavities

Intervention Type: DEVICE

Standard 30° 4mm Endoscope

The Standard 30° 4mm endoscopic sinus evaluation is the standard procedure that would normally be used to evaluate the condition of each participant.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3NT Medical Ltd.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Joshua M. Levy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Hospital Midtown

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00110282

Identifier Type: -

Identifier Source: org_study_id