Sinus ProblemNCT04096482
Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses
A study testing Peregrine Drivable ENT Scope and Standard 30° 4mm Endoscope in people with Sinus Problem, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Problem
- What is being tested?
- Peregrine Drivable ENT Scope and Standard 30° 4mm Endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any medical disorder which in the investigator's judgment contraindicates the patient's participation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS
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
Read the 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
- Being tested
- Peregrine Drivable ENT Scope, Standard 30° 4mm Endoscope
- Keywords
- Nasal endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peregrine Drivable ENT ScopeDevice
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 EndoscopeDevice
The Standard 30° 4mm endoscopic sinus evaluation is the standard procedure that would normally be used to evaluate the condition of each participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Peregrine Drivable ENT Scope; Device: Standard 30° 4mm Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 (after each endoscopy)
Secondary outcomes (5)
Number of Participants With Adequate or Inadequate Image Quality From Peregrine 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.
Measured: Day 1 (after each endoscopy)
Visual Analogue Scale (VAS) Tolerability Score
Participant tolerability was evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = highly tolerable and 10 = not tolerable.
Measured: Day 1 (after each endoscopy)
VAS Pain Score
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.
Measured: Day 1 (after each endoscopy)
Impact on Clinical Workflow
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.
Measured: Day 1 (after each endoscopy)
Ease of Use
The ease of use of each endoscope procedure was rated by physicians on a 5-point scale where 1 = worst and 5 = best.
Measured: Day 1 (after each endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start5 Nov 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Early findings identified the need to update the design of the study device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sinus ProblemStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- 3NT Medical Ltd.
- Responsible party
- Principal investigator, Joshua M. Levy, Emory University
- Investigators
- Joshua Levy, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096482
- Sponsor's protocol ID
- IRB00110282
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2019
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual participant data collected during the trial and after deidentification will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS
- ClinicalTrials.gov ID
- NCT04096482
- Acronym / sponsor ID
- IRB00110282
- Conditions
- Sinus Problem
- Keywords
- Nasal endoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early findings identified the need to update the design of the study device.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- 3NT Medical Ltd.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 20 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard 30° 4mm Endoscope Followed by Peregrine Endoscope | Experimental | Device: Peregrine Drivable ENT Scope, Device: Standard 30° 4mm EndoscopeParticipants will receive an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Any medical disorder which in the investigator's judgment contraindicates the patient's participation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peregrine Drivable ENT ScopePeregrine, 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 Followed by Peregrine Endoscope |
| Standard 30° 4mm EndoscopeThe Standard 30° 4mm endoscopic sinus evaluation is the standard procedure that would normally be used to evaluate the condition of each participant. | Device | Standard 30° 4mm Endoscope Followed by Peregrine Endoscope |
Primary outcome
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy
Time frame: Day 1 (after each endoscopy)
Visual Analogue Scale (VAS) Tolerability Score
Time frame: Day 1 (after each endoscopy)
VAS Pain Score
Time frame: Day 1 (after each endoscopy)
Impact on Clinical Workflow
Time frame: Day 1 (after each endoscopy)
Ease of Use
Time frame: Day 1 (after each endoscopy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial and after deidentification will be available for sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Levy, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peregrine Drivable ENT Scope and Standard 30° 4mm Endoscope in people with Sinus Problem, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Visualization Success of Maxillary Sinus Anatomy (time frame: Day 1 (after each endoscopy)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.