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

Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04096482

Enrollment

Registered

2019-09-19

Start date

2019-11-05

Completion date

2020-09-01

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Problem

Keywords

Nasal endoscopy

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.

Interventions

DEVICEPeregrine 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

DEVICEStandard 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from Emory University Hospital Midtown in Atlanta, Georgia, USA. Participant enrollment began November, 5, 2019 and all follow up was complete by September 1, 2020.

Participants by arm

Arm	Count
Standard Endoscope Followed by Peregrine Drivable ENT Scope Participants with prior endoscopic sinus surgery (EES) scheduled for nasal endoscopy who are receiving an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.	6
Total	6

Baseline characteristics

Characteristic	Standard Endoscope Followed by Peregrine Drivable ENT Scope
Age, Continuous	50.83 years STANDARD_DEVIATION 17.73
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	2 Participants
Region of Enrollment United States	6 Participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 6
other Total, other adverse events	0 / 6	0 / 6
serious Total, serious adverse events	0 / 6	0 / 6

Outcome results

Primary

Number of Participants With Visualization Success of Frontal Sinus Anatomy

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.