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

NCT04096482 | Terminated Results FDA Device

• 1 other identifier: IRB00110282
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Sinus Problem

Keywords

Nasal endoscopy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Visualization Success of Maxillary Sinus Anatomy

  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.

  Day 1 (after each endoscopy)

• 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.

  Day 1 (after each endoscopy)

• Number of Participants With Visualization Success of Sphenoid Sinus Anatomy

  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.

  Day 1 (after each endoscopy)

Secondary Outcomes (5)

• Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy

  Day 1 (after each endoscopy)

• Visual Analogue Scale (VAS) Tolerability Score

  Day 1 (after each endoscopy)

• VAS Pain Score

  Day 1 (after each endoscopy)

• Impact on Clinical Workflow

  Day 1 (after each endoscopy)

• Ease of Use

  Day 1 (after each endoscopy)

Study Arms (1)

Standard 30° 4mm Endoscope Followed by Peregrine Endoscope

EXPERIMENTAL

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

Device: Peregrine Drivable ENT Scope; Device: Standard 30° 4mm Endoscope

Interventions

Peregrine Drivable ENT Scope 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 Followed by Peregrine Endoscope

Standard 30° 4mm Endoscope DEVICE

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

Standard 30° 4mm Endoscope Followed by Peregrine Endoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead
• 3NT Medical Ltd.: collaborator

Study Sites (1)

Emory Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Interventions

Endoscopes

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Results Point of Contact

• Title: Joshua M Levy
• Organization: Emory University

joshua.levy2@emory.edu

(404) 778-3381

Study Officials

• Joshua Levy, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: November 5, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 15, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing immediately following the embargo period associated with publication.
• Access Criteria: Data will be available for sharing with primary investigators at academic institutions for the purposes of meta-analysis or nested studies with agreed publication plan. Data can be requested by contacting the study team and completing a data sharing agreement.

Locations

US (1)