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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096482
Recruitment Status : Suspended (Study is temporarily on hold pending updates and supplies from the sponsor.)
First Posted : September 19, 2019
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
3NT Medical Ltd.
Information provided by (Responsible Party):
Joshua M. Levy, 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

Condition or disease Intervention/treatment Phase
Sinus Problem Device: Peregrine Drivable ENT Scope Device: Standard 30° 4mm Endoscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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 Peregrine Endoscope as well as the standard endoscope. The surgeon will decide which endoscopy is performed first.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Peregrine Drivable ENT Scope Followed by Standard Endoscope
Participants will receive an endoscopy with the Peregrine Drivable ENT Scope followed by an endoscopy with the standard 30° 4mm endoscope.
Device: 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

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.

Active Comparator: 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.
Device: 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

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.




Primary Outcome Measures :
  1. Visualization of Maxillary Sinus Anatomy [ Time Frame: Day 1 (after each endoscopy) ]
    The ability of each endoscope type to visualize the maxillary sinus anatomy (ostium, anterior wall, lateral aspect, floor) will be assessed as being a success or failure.

  2. Visualization of Frontal Sinus Anatomy [ Time Frame: Day 1 (after each endoscopy) ]
    The ability of each endoscope type to visualize the frontal sinus anatomy (ostium, posterior wall, anterior wall, lateral recess) will be assessed as being a success or failure.

  3. Visualization of Sphenoid Sinus Anatomy [ Time Frame: Day 1 (after each endoscopy) ]
    The ability of each endoscope type to visualize the sphenoid sinus anatomy (ostium, sella, floor, lateral recess) will be assessed as being a success or failure.


Secondary Outcome Measures :
  1. Image Quality from Peregrine Endoscopy [ Time Frame: 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.

  2. Visual Analogue Scale (VAS) Tolerability Score [ Time Frame: Day 1 (after each endoscopy) ]
    Participant tolerability will be evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = highly tolerable and 10 = not tolerable.

  3. VAS Pain Score [ Time Frame: Day 1 (after each endoscopy) ]
    Participant pain will be 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.

  4. Impact on Clinical Workflow [ Time Frame: Day 1 (after each endoscopy) ]
    The impact on clinical workflow of visual information obtained by each endoscope procedures will be rated by physicians on a 5-point scale where 1 = worst and 5 = best.

  5. Ease of use [ Time Frame: Day 1 (after each endoscopy) ]
    The ease of use of each endoscope procedure will be rated by physicians on a 5-point scale where 1 = worst and 5 = best.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096482


Locations
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United States, Georgia
Emory Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
3NT Medical Ltd.
Investigators
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Principal Investigator: Joshua Levy, MD Emory University
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Responsible Party: Joshua M. Levy, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT04096482    
Other Study ID Numbers: IRB00110282
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data collected during the trial and after deidentification will be available for sharing.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joshua M. Levy, Emory University:
Nasal endoscopy