Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
Phase: NA
Conditions: Chronic Rhinosinusitis
Sponsor: Icahn School of Medicine at Mount Sinai

Utilization of a Microcurrent Device for Postoperative Pain Following Functional 
Endoscopic Sinus Surgery: a Randomized Controlled Trial
PI: Alfred-Marc Iloreta, MD
NCT05198518
Document Date: 1-22-2024

Protocol Title: 
Utilization of a microcurrent device for postoperative pain 
following functional endoscopic sinus surgery: a 
randomized controlled trial
Principal Investigator: 
Alfred Iloreta, MD
Sponsor: 
Icahn School of Medicine at Mount Sinai
Study ID:
21-01392
Protocol Ref:
CLP005
Revision Date: 
16-Feb-2023
Revision
Date
Description of Change
V0.1
Initial release
V0.2
8.27.2021
Draft Finalized protocol for IRB submission
V0.3
9.16.2021
Updated with ISMMS/Sponsor language 
V0.4
9.20.2021
Updated with Data Ownership and Publication Agreement
V0.5
10.27.2021
Updated inclusion/exclusion criteria
V0.6
11.5.2021
Updated inclusion/exclusion criteria
V0.7
1.10.2022
Updated inclusion/exclusion criteria
V0.8
3.29.2022
Added incentive for study completion
V0.9
4.5.2022
Updated consent section to allow for e-consenting
V1.0
2.3.2023
 The rationale for the study Modification: to Expand and 
capture other patients seen by providers at the same FPA who 
qualify for functional nasal and endoscopic sinus surgery, in an 
effort to accelerate recruitment and enrollment to meet study 
end date in 10/31/2023.
1) Changing final inclusion criteria to VAS >0 postop (instead of
Postop pain VAS ≥ 5 in PACU).
Effective Date: 1/22/2024
End Date:10/30/2024

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Justification:  We are aiming to include participants 
who can benefit from the treatment to reduce postoperative 
pain at home and have seen that there is a time lag in pain 
which potentially increases after discharge. Therefore, we are 
amending the final inclusion criteria from Postop pain VAS ≥ 5 
in PACU, where analgesia can still be in effect, to VAS >0 postop 
which will better capture the population of interest. 
2)  Revising the subject demographics questionnaire
Justification: We have added 'Procedure to be Performed, 
Physician performing procedure, Tissue to be Operated On and 
Additional procedure details (such as splints, etc.)' to the 
demographic form to capture additional information that will 
allow us to segment results of the primary endpoint of acute 
change in peak postoperative pain
3)  Updated Post-op timelines day 7 and day 14 to allow follow-
up up to 21 post-surgeries to accommodate change in patient 
and clinic scheduling that occur for varying reasons 
4) Updated Study Population to expand scope to include 
patients electing for functional nasal surgery, common among 
patients requiring functional rhinoplasty or reconstructive 
surgery  
5) Rephrasing Compensation language 
V1.1
1.17.2024
Increased recruitment numbers from 100 to 130.
Justification: due to high drop-out rate post randomization; 
there is the need to increase the recruitment numbers to reach 
the target of 60 completed participants.
Effective Date: 1/22/2024
End Date:10/30/2024

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STUDY SUMMARY:
Title
Utilization of a microcurrent device for postoperative pain following 
functional endoscopic sinus surgery: a randomized controlled trial
Purpose
The purpose of this study is to investigate whether daily use of a 
microcurrent neuromodulation device will decrease the pain experienced 
by patients in the days following functional  nasal andsinus surgery , 
including pain during postoperative debridement following Endoscopic 
sinus surgery
Study Design and 
Duration
A prospective randomized controlled study of 60 recruited subjects 
undergoing  functional nasal or sinus surgery. Enrolled subjects will be 
randomized (1:1) to receive either an active neuromodulation study 
device or a sham device that appears identical to the active device while 
emitting no therapeutic microcurrent. Subjects will self-treat with the 
device at home and will be followed for a minimum of 2 weeks after 
surgery up to 21 days post-surgery.
Target Subject 
Population
60 subjects undergoing  functional nasal or sinus surgery
Subject Inclusion Criteria

Scheduled for FESS or Functional Rhinoplasty

Possessing an American Society of Anesthesiologists physical status 
classification of I or II

Age ≥ 18

Possess the capacity to give informed consent

Able to read write and understand English or Spanish

Able to attend follow up visits at postop Visit 1 (within 0 – day 14) and 
post-op Visit 2 (within 10 – 21 days)

Postop pain VAS > 0  in PACU phase II
Subject Exclusion Criteria

Does not meet inclusion criteria

History of chronic pain

Experiencing chronic pain requiring opioids at baseline and/or who 
are under the care of pain management specialists

Seizure disorders

Undergoing planned or unplanned additional procedures at the time 
of surgery

Planned procedure involves nerve cryoablation

In custody of the state

Prisoners

Known to be pregnant

Implanted cranial metallic components or devices including deep brain 
stimulators or cochlear implants

Has an implanted or external worn cardiac device including 
pacemakers, automated implantable cardioverter defribrillator (AICD), 
or any other cardiac electric devices (including non-implanted 
devices, e.g. defibrillator vest)
Effective Date: 1/22/2024
End Date:10/30/2024

STUDY-21-01392 | Alfred-Marc Iloreta, MD
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Study Endpoints 

Analgesic Efficacy

Safety
Investigator
Alfred-Marc Iloreta, Jr. MD
234 East 85th Street
4th Floor
New York, NY 10028
Industry Collaborator
Tivic Health Systems
750 Menlo Ave, #200
Menlo Park, CA 94025
Contact:
Blake.gurfein@tivichealth.com
5615737652
Effective Date: 1/22/2024
End Date:10/30/2024

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Contents
1.  BACKGROUND AND RATIONALE................................................................................................6
2.  DESCRIPTION OF THE STUDY DEVICE.........................................................................................6

INDICATIONS FOR USE........................................................................................................7

STUDY OBJECTIVES .............................................................................................................7

STUDY DESIGN ....................................................................................................................7

SUBJECT POPULATION........................................................................................................9

INCLUSION/EXCLUSION CRITERIA.......................................................................................9
Exclusion Criteria .....................................................................................................................................9

STUDY PROCEDURES...........................................................................................................9

Subject Screening.............................................................................................................................9

Randomization...............................................................................................................................10

Blinding...........................................................................................................................................10

Study procedure.............................................................................................................................10

Data analysis ..................................................................................................................................11

STUDY ENDPOINTS ...........................................................................................................12

INDUSTRY COLLABORATOR AND INVESTIGATOR OBLIGATIONS ......................................12

IRB Review/Approval/Reporting...................................................................................................12

Informed Consent ..........................................................................................................................12

Study Discontinuation and Closure ...............................................................................................13

Confidentiality and Privacy............................................................................................................13

Data Retention...............................................................................................................................14

Protocol Deviations/Amendments................................................................................................14

Study Monitoring ...........................................................................................................................15

Adherence to the Protocol.............................................................................................................16

Emergency Modifications ..............................................................................................................16

Other Reportable New Information and Protocol Deviations/Violations....................................16

Adverse Event Reporting ...............................................................................................................16

Potential Benefits...........................................................................................................................17

COST .................................................................................................................................17

COMPENSATION...............................................................................................................17

STUDY QUALITY CONTROL AND QUALITY ASSURANCE ....................................................17

Site Training ...................................................................................................................................17
Effective Date: 1/22/2024
End Date:10/30/2024

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
Compliance to Standards and Regulations....................................................................................17

Quality Assurance Audit ................................................................................................................17

PUBLICATION POLICY........................................................................................................18

ClinicalTrials.org Registration ...........................................................................................18

CONFIDENTIALITY .............................................................................................................18
Effective Date: 1/22/2024
End Date:10/30/2024

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1.  BACKGROUND AND RATIONALE
The opioid epidemic is driven by opioid misuse, addiction, and overdose. 10.3 million people misused 
prescription opioids in 20181.  There are over 1 million sinus surgeries in US every year and the majority 
of sinus surgery patients are given opioid medications to treat postoperative pain.  Otolaryngologists have 
become more vigilant in their prescription practices, however, non-opioid pain management solutions are 
needed to further reduce dependence on opioid drugs. Strategies to avoid or minimize opioid 
consumption while effectively managing patient pain are of the utmost importance. Furthermore, patient 
apprehension over the pain experienced during postoperative debridements often negatively impacts 
patient adherence to postoperative visits. Several non-opioid alternative medications have proven 
efficacious in postoperative pain management following a variety of otolaryngology surgeries. Non-
medication alternatives, such as pain management devices, remain uncharted territory. Tivic Health 
previously developed and received FDA clearance for ClearUP Sinus Pain Relief, a non-invasive 
microcurrent emitting device applied to the face.  ClearUP was found to be safe and highly effective at 
reducing facial pain.  In the current study, we use the same form factor for ClearUP with minor 
modifications to the waveform emitted by the device to assess its feasibility for use at home in treating 
post-operative pain after sinus surgery. The microcurrent study device has yielded auspicious results in a 
pilot studies examining its ability to reduce postoperative pain following functional endoscopic sinus 
surgery (FESS). We hypothesize that daily use of the self-administered, handheld, microcurrent study 
device will reduce patients’ pain levels following functional nasal or sinus surgery, thereby lowering the 
need for analgesic medications.
1. https://www.cdc.gov/drugoverdose/featured-topics/abuse-prevention-awareness.html
2.  DESCRIPTION OF THE STUDY DEVICE
The study device is a handheld micro-current TENS emitter intended to be used for the relief of 
postoperative pain after functional nasal or sinus surgery.  The device uses an average current that is 
several orders of magnitude smaller than that of TENS devices used in the facial area. The design of the 
study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated 
with the sinuses.
The pear-shaped device is held in the hand, with the rounded tip of the device applied to the facial skin in 
the region of skin overlying the sinus passages for 5 minutes per treatment. The tip is the active electrode 
of a monopolar design. The housing of the device serves as the return electrode. The hand holding the 
device completes the electrical path. 
When the user turns the device on and presses the tip to the skin, the device lights up and initiates a low-
frequency, pulsed AC circuit that is maintained at a constant current. The device uses the current to 
calculate the impedance in the path between the tissue at the tip and the hand in contact with the device. 
If the calculated impedance is above an impedance threshold, the device is in “Detection” mode. 
Conversely, when the impedance falls below the impedance threshold, the device enters a “Treatment” 
Effective Date: 1/22/2024
End Date:10/30/2024

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mode. The impedance threshold is calculated dynamically by an adaptive algorithm that incorporates the 
measured parameters of the individual user.
The user is instructed to glide the tip of the device along the skin along the cheek, nose and under brow 
bone. When a low-impedance point is detected, the device signals the user via a slight haptic (vibration) 
feedback. The user is instructed to hold the device in place until the Treatment period has passed as 
indicated by cessation of the haptic indicator.
Once the Treatment period ends, the device resets to Detection mode. The user is instructed to glide the 
device along an indicated path until reaching the next low-impedance area.
The user may adjust the current setting of the device (low, medium, high) if they prefer more or less 
current intensity. The default setting for the device is low.
The study device emits a 14.7 Hz frequency and has previously shown to be safe and well-tolerated in an 
IRB-approved 4 person pilot feasibility study. The study device is configured to emit alternating current in 
the microampere range, significantly less energy than has been safely used in TENS treatment of the face 
for pain [1-3].
1.
Hansson, P., & Ekblom, A. (1983). Transcutaneous electrical nerve stimulation (TENS) as 
compared to placebo TENS for the relief of acute oro-facial pain. Pain, 15(1-4), 157-165.
2.
Hansson, P., Ekblom, A., Thomsson, M., & Fjellner, B. (1986). Influence of naloxone on relief of 
acute oro-facial pain by transcutaneous electrical nerve stimulation (TENS) or 
vibration. Pain, 24(3), 323-329.
3.
Bremerich, Andreas, et al. "Transcutaneous electric nerve stimulation (TENS) in the therapy of 
chronic facial pain: Preliminary report." Journal of Cranio-Maxillofacial Surgery 16 (1988): 379-
381.
The sham device appears and operates identically to the active device, including indicator lights and haptic 
vibration, however it emits a weak direct current that is non-therapeutic.

INDICATIONS FOR USE 
The study device is being evaluated for use in the treatment of postoperative pain after functional nasal 
or sinus surgery. 

STUDY OBJECTIVES
The purpose of this study is to investigate whether daily use of a microcurrent study device will decrease 
the pain experienced by patients in the days following functional nasal or sinus surgery, including 
during postoperative debridements.
Effective Date: 1/22/2024
End Date:10/30/2024

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
STUDY DESIGN
A prospective randomized controlled study of 60 recruited subjects undergoing  functional nasal or 
sinus surgery. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation 
study device or a sham device that appears identical to the active device while emitting no therapeutic 
microcurrent. Subjects will self-treat with the device after surgery while in the PACU Phase II and at home 
for a minimum of two weeks. Study visits will include enrollment, the day of the surgical procedure, and 
two postoperative debridement visits both to be completed at the end of day 21 post-op. Subjects will 
record data on pain, medication use, and congestion symptoms at home. At the second postop study visit, 
the study device will be returned and subjects will complete questionnaires related to sinonasal symptoms 
and user experience.
Study Flow & Data Collection
Study Participant Timeline
T = Enrollment Visit

Confirm eligibility and obtain informed consent

Patient demographics

SNOT22 and NOSE scores

Instruct patient in use of device
T = 0 days 

Date of Surgery.

Participant screened for study inclusion based on post-operative pain score.

Participant instructed in use of study device.

Use of device and measurement of pre and post pain level
T = 1-14 days 

Participant uses study device and records pain before and after usage in pain 
diary

Participant records medication usage in medication diary
T = 6-14 days 

Participant seen for their regularly scheduled post-operative visit #1 

Device usage before and after debridement (applicable to FESS patients)
T = 0 -21 days 

Participant continues to use study device and record pain diary and medication 
diary
T = 12 – 21 days 

Participant seen for their regularly scheduled post-operative visit #2 

Device usage before and after debridement (applicable to FESS patients)

Termination of participation in study protocol. Collection of study device

Patient completes user experience survey
Enrollment Visit (Clinic)

Confirm eligibility & consent

Subject Demographics

Nasal Obstruction Symptom Evaluation

Sino-Nasal Outcome Test 22

Device and study protocol training 
Postop Day 0 Visit (PACU Phase II)

Confirm postoperative pain VAS > 0
Effective Date: 1/22/2024
End Date:10/30/2024

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
Collect VAS before and after first study device use 
Postop Day 0-21 (At Home)

Record VAS before and after study device use (before, 10 mins, 2 hours, 4 hours)

Record medication use daily
Postop Visit 1 (V1) (Clinic)

Complete Nasal Obstruction Symptom Evaluation

Record VAS before and after study device use, during debridement, after debridement (applicable 
to FESS patients)
Postop - Visit 2 (V2) (Clinic)

Complete Nasal Obstruction Symptom Evaluation

Complete Sino-Nasal Outcome Test 22

Record VAS before and after study device use, during debridement, after debridement (applicable 
to FESS patients)

Return device

User Experience Questionnaire

SUBJECT POPULATION
It is anticipated that 130 subjects will be recruited to achieve a sample size of 60 participants, accounting 
for potential drop-outs and/or screen failures. Any subject that meets all the inclusion and none of the 
exclusion criteria may be eligible to participate in the study. 

INCLUSION/EXCLUSION CRITERIA
All subjects meeting the following inclusion criteria will be eligible to participate in this study. 
Inclusion Criteria

Scheduled for  functional nasal or sinus surgery

Possessing an American Society of Anesthesiologists physical status classification of I or II

Age ≥ 18

Possess the capacity to give informed consent

Able to read write and understand English or Spanish

Able to attend follow up visits at postop Visits 1 and 2

Postop pain VAS >0  in PACU phase II
Exclusion Criteria

Does not meet inclusion criteria

History of chronic pain

Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain 
management specialists

Seizure disorders

Undergoing planned or unplanned additional procedures at the time of surgery
Effective Date: 1/22/2024
End Date:10/30/2024

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
Planned procedure involved nerve cryoablation

In custody of the state

Prisoners

Known to be pregnant

Implanted cranial metallic components or devices including deep brain stimulators or cochlear 
implants

Has an implanted or external worn cardiac device including pacemakers, automated implantable 
cardioverter defribrillator (AICD), or any other cardiac electric devices (including non-
implanted devices, e.g. defibrillator vest)

STUDY PROCEDURES
All study procedures involving subject participation will be conducted according to good clinical practices 
(GCP) and in compliance with the principles enunciated in the Declaration of Helsinki.  All study procedures 
will be performed at an Investigational Site, under the direction of an Investigator or designee, and at 
which this protocol will be approved by:
Icahn School of Medicine IRB
1 Gustave L. Levy Place
New York, NY 10029

Subject Screening
Subjects with a planned functional nasal or sinus surgery will be recruited with the recommendation 
of the attending physician during their preoperative office visit. The attending physician or research 
personnel will determine if the subject meets inclusion criteria and does not meet exclusion criteria 
during their routine preoperative visit (with the exception of postop pain).

Randomization
Eligible subjects that elect to enroll will be randomized via block randomization and assigned to either 
active or sham study device groups.

Blinding
The study will be double-blind – neither the investigators nor the study subjects will know which group 
is receiving active or sham treatment. Unblinding will occur after all data has been collected for all study 
subjects. 

Study procedure
Patients undergoing standard functional nasal or sinus surgery will be recruited with the 
recommendation of the attending physician during their preoperative office visit. The attending physician 
or research personnel will determine if the subject meets inclusion criteria and does not meet exclusion 
criteria during their routine preoperative visit (with the exception of postop pain). If the patient elects to 
enroll in the study, the following data will be collected from their medical record:
Effective Date: 1/22/2024
End Date:10/30/2024

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-
Basic demographic information: age, sex, insurance status, race and ethnicity
-
Medical history: history of opioid use or chronic pain, medication list, allergies, preoperative pain 
level, other past medical history
In their final preoperative visit, subjects will complete the Sinonasal Outcome Test 22 (SNOT22) and a 
modified version of the Nasal Obstruction Symptom Evaluation (NOSE). Patients will be instructed by 
study staff on how to correctly self-administer the device to the periorbital skin. Subjects will be 
randomized in a 1:1 fashion to one of two groups and given either an active study device or a sham device 
that appears identical to the active device while emitting no therapeutic microcurrent. These devices will 
be labeled “A” or “B” depending on the group randomization. Both groups will be instructed to use the 
device on postoperative days 0-21 and sent home with instructions.
On the day of surgery, standard total intravenous anesthesia (TIVA) will be administered for each enrolled 
subject. Standard TIVA is as follows: anesthetic induction will be performed using propofol 1.5-2.5 mg/kg 
and remifentanil 2-5 mcg/kg, with neuromuscular blockade used to facilitate endotracheal intubation only 
if deemed necessary by the anesthesiologist placing the endotracheal tube (ETT). Anesthesia will be 
maintained using propofol 30-50 mcg/kg/min, remifentanil 0.05-0.5 mcg/kg/min and nitrous oxide 50-
70% titrated based on hemodynamics to maintain a mean arterial pressure of 60-70 mmHg. Each subject 
will receive the standard dose of 10 mg intravenous dexamethasone prior to the start of surgery, and 4 
mg ondansetron prior to emergence. Vital signs, anesthetic technique (i.e., bolus and infusion drug totals, 
end tidal gas concentrations, narrative comments), and inputs and outputs for the case will be recorded 
to control hemodynamic differences between subjects. No new imaging will be obtained as part of the 
study. In PACU phase II, subjects will report their visual analog scale (VAS) for pain to confirm eligibility 
for the study.  Subjects will complete their first study device treatment in the PACU phase II and study 
staff will record their VAS for pain before treatment and 10 minutes and 1 hour after treatment. Subjects 
will be instructed to record their VAS for pain at 2 hours and 4 hours after treatment at home.
The day after surgery, subjects will be reminded by staff members via phone to self-administer the 
treatment with the device. Subjects will glide the device over the periorbital skin for 2.5 minutes per side 
of the face (five minutes total) three times every 24 hours for up to V2 or 21 days post-op, whichever 
comes sooner with additional administrations as needed. When in pain, subjects will be instructed to use 
the device and wait ten minutes before using oxycodone 5 mg or acetaminophen 325 mg as rescue pain 
medication if needed. Subjects will complete a daily pain diary (either paper or online via REDCap) 
documenting their pain on a visual analog scale of 0-10 before and 10 minutes, 1 hour, 2 hour, 4 hours 
after treatment.  Subjects will also record the time and dose of all medications used (either paper or online 
via REDCap). The questions asked are as follows:
-
How many times did you administer the device today?
-
How many acetaminophen 325 mg have you taken in the last 24 hours?
-
How many oxycodone 5 mg have you taken in the last 24 hours?
Effective Date: 1/22/2024
End Date:10/30/2024

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-
Were you able to complete your daily work activities?
-
Were you able to complete your daily non-work activities?
 Subjects will return to clinic for their first two postoperative visits o . On postoperative V1 and V2 subjects 
will complete a modified version of the NOSE questionnaire to quantify changes in congestion and nasal 
obstruction. Post-op V2 subjects will complete the SNOT-22 to capture other sinonasal symptoms. For 
patients undergoing debridement, upon arriving in clinic, subjects will be instructed to record their current 
pain level via VAS in their pain diary before and after they self-administer treatment with the study device. 
They will subsequently record their pain levels during and after the debridement. During the second 
postop visit, subjects will be asked to complete a user experience questionnaire assessing their 
satisfaction with the study device and safety/tolerability. 

Data analysis
All data will be tabulated. The difference between the symptom scores before and after treatment will 
be computed for each individual in the study. Differences in change scores will be compared across 
treatment groups.
An appropriate two-sided statistical test (paired t-test or repeated measure ANOVA) will be used to 
assess the pre and post differences in symptom severity.

STUDY ENDPOINTS 
This study is intended to assess the analgesic efficacy and safety of the study device after functional 
nasal or sinus surgery.  The primary endpoint is the acute change in peak postoperative pain score 10 
minutes after treatment.
Auxiliary outcomes include:

Pain at 1 hour, 2 hours, 4 hours after device treatment

Pain before, during, and after debridement (applicable to FESS patients)

Postoperative debridement compliance (applicable to FESS patients)

Self-report of congestion and nasal obstruction severity

Total opioid and/or acetaminophen consumption (the former calculated in oral 
morphine equivalents)

Patient satisfaction 

Safety and tolerability

Direct and indirect cost of pain management as calculated by total medications used 
and number of days missed from usual daily activity

Utilization of additional healthcare resources (including telephone encounters and visits 
to any healthcare provider regarding postoperative pain)
Effective Date: 1/22/2024
End Date:10/30/2024

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
INDUSTRY COLLABORATOR AND INVESTIGATOR OBLIGATIONS

 IRB Review/Approval/Reporting 
The final protocol and Informed Consent for this study will be reviewed and approved by the appropriate 
duly constituted Institutional Review Board (IRB) prior to the enrollment of subjects into the study.  It is 
the responsibility of the Investigator to assure that all aspects of the institutional review are conducted in 
accordance with current United States Food and Drug Administration (FDA) regulations. The Industry 
Collaborator must receive a letter documenting the IRB approval that specifically identifies the protocol 
by title, prior to initiation of the study.  
After the completion or termination of the study, the Investigator will submit a final report to the IRB and 
to the Industry Collaborator.

 Informed Consent
It is the responsibility of the Investigator to assure that Informed Consent is obtained from each subject 
in accordance with current regulations. The content of the Informed Consent should conform to current 
ICH and FDA guidelines for the protection of human subjects, and/or to the specific IRB requirements. 
The Informed Consent form must be in English, signed and dated by the subject and Investigator or 
designee. 
Each subject will be given verbal and written information describing the nature and duration of the study.  
This shall take place under conditions where the subject has adequate time to consider the risks 
associated with his/her participation in the study. All subjects’ questions must be answered adequately 
to ensure that they have the information they require to make an informed decision about participation 
in the study.  Informed consent may be obtained from patients either in-person or via the eConsent 
framework provided by RedCAP. In the case of eConsent, study staff will set-up a phone call with the 
potential subject in order to explain the study, elicit feedback and understanding from the patient, and 
answer any outstanding questions. The signed Informed Consent form will be filed in a study file along 
with all study forms.
Subjects must not be tested until they sign an Informed Consent form.  

Study Discontinuation and Closure
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants and the investigators. If the study 
is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the Institutional Review Board (IRB), and sponsor and will provide the reason(s) for the 
termination or suspension.  Study participants will be contacted, as applicable, and be informed of 
changes to study visit schedule. 
 
Effective Date: 1/22/2024
End Date:10/30/2024

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Circumstances that may warrant termination or suspension include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants

Demonstration of efficacy that would warrant stopping  

Insufficient compliance to protocol requirements

Data that are not sufficiently complete and/or evaluable

Determination of futility

Confidentiality and Privacy
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover the clinical 
information relating to participants. Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the study, or the data 
will be released to any unauthorized third party without prior written approval of the sponsor.
All research activities will be conducted in as private a setting as possible.
Authorized representatives of the Institutional Review Board (IRB) may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records.
The study participant’s contact information will be securely stored at the clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB or Institutional policies.

Data Retention
The Investigator will maintain adequate records for the study including the Subject Demographics log, 
Data Collection sheets, Informed Consent forms, information regarding discontinued subjects, and other 
pertinent data. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored on the password protected, encrypted Mount Sinai network, and/or HIPAA 
compliant REDCap database. Hard copies of study records will be maintained in a locked cabinet within 
the Department of Otolaryngology, accessible only to the PI and study team members. Participant’s 
Effective Date: 1/22/2024
End Date:10/30/2024

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identifiable information will be stored separately and linked to the research data through the use of a 
unique study identification number. At the end of the study, all study databases will be de-identified and 
stored for up to 6 years following the completion of the study. 
The original study record will consist of:
▪
Subject Demographics Questionnaire
▪
Pain Data Sheet(s)
▪
Debridement Pain Data Sheet
▪
Medication Data Sheet(s)
▪
NOSE Data Sheet (Enrollment, Postop V1, Postop V2)
▪
SNOT22 Data Sheet (Enrollment, Postop V2)
▪
User Experience Questionnaire
Original study records will be filled out manually by study staff and the study patient, where applicable. If 
an entry requires change, the correction will be made as follows:

Draw a single line through the incorrect entry.

Enter data, date, and initial the change (“white-out”, erasure, or any form of obliteration of data is 
not permitted under any circumstances).
All fields must be completed in study records. Blank responses will not be interpreted as “none” or “N/A”.  
If data are not available, a straight line should be drawn through all applicable fields and unused pages, 
dated and initialed to indicate there was no omission.
After completion of the study, the Investigator will provide the Industry Collaborator with deidentified 
digital copies of study databases and the original study record.

Protocol Deviations/Amendments
The Investigator shall not deviate from the protocol without documented approval from the Industry 
Collaborator. Any significant changes or deviations in the protocol will be made as an amendment to the 
protocol and must be approved in writing by the IRB and by the Industry Collaborator prior to being 
implemented.  Unless the Industry Collaborator has consented to any such deviation or change in writing, 
the Industry Collaborator will not assume any resulting responsibility or liability.
Amendments to the protocol will be subject to the same requirements as the original protocol, with the 
exception of administrative amendments. The Industry Collaborator will submit a protocol amendment 
via the Investigator to the IRB for any change in the protocol that significantly affects the safety of subjects 
or scope of the investigation.
Administrative amendments may be made by mutual agreement between the Investigator and the 
Industry Collaborator and will be documented in writing with copies to both the Investigator and the 
Industry Collaborator.
Effective Date: 1/22/2024
End Date:10/30/2024

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
 Study Monitoring
The individual(s) at the Icahn School of Medicine at Mount Sinai (ISMMS) who will be responsible for data 
and safety monitoring of this study. 
ISMMS Principal Monitor:
Principal Investigator
Last Name: Iloreta
First Name: Alfred-Marc
Academic Title: Assistant Professor
Department: Otolaryngology
Mailing Address: 
1 Gustave L Levy Place
10th Floor
New York, NY 10020
Phone: Office 212-241-9410
E-mail: Alfred-Marc.Iloreta@mountsinai.org 
Dr. Iloreta will be the principal monitor for this study. The majority of study patients will be under his care. 
He will be best positioned to assess and respond to any adverse events that are reported.
Safety and data information will be reviewed by the monitors every 6 months.
Data will be recorded in patient binders and secure Mount Sinai network drive folder and REDCap 
database, ensuring completeness and accuracy through redundancy. Data will also be checked at set 
intervals by the study team.
If temporary or permanent suspension of the study occurs, the occurrence will be reported to the IRB.

Adherence to the Protocol
Except for an emergency situation in which proper care for the protection, safety, and well-being of the 
study patient requires alternative treatment, the study shall be conducted exactly as described in the 
approved protocol. 

Emergency Modifications
Investigators may implement a deviation from, or a change of, the protocol to eliminate an immediate 
hazard(s) to trial subjects without prior IRB approval. 

Other Reportable New Information and Protocol Deviations/Violations
Effective Date: 1/22/2024
End Date:10/30/2024

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In accordance with local IRB requirements, the following information must be reported within five (5) 
business days. 
o
Non-compliance with federal regulations governing human research or with the 
requirements or determinations of the IRB, or an allegation of such non-compliance
o
Failure to follow the protocol due to the action or inaction of the investigator or research 
staff.
o
Breach of confidentiality
o
Premature suspension or termination of the research by the sponsor or investigator. 

Adverse Event Reporting
A significant adverse event (SAE) is one that has a serious adverse effect on the health or safety of a 
subject or causes any life-threatening problem or death of the study subject. 
All SAEs should be recorded by the Investigator and reported by the Investigator to the Industry 
Collaborator and to the IRB the next business day after the Investigator becomes aware of the SAE. 
The Investigator will collect adverse effects information and will report serious and unanticipated adverse 
effects to the Industry Collaborator and IRB. The Investigator will terminate the study within five working 
days if the Investigator and Industry Collaborator determine that the adverse system effects present an 
unreasonable risk to subjects (21 CFR 812.46(b) (2)).
An adverse event (AE) during a clinical evaluation is “any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device.” It is not dependent on 
whether the event is considered to be related to the investigational product or the study.  An adverse 
event includes events not seen at the beginning of the study or worsened if present at the beginning.
All AEs observed by the Investigator or reported by the subject will be documented (including all 
symptoms) and included in the study file.  

Potential Benefits
There is no guaranteed benefit to a subject for participation in this study. 

COST
There will be no additional charge to subjects for any study procedures.

COMPENSATION
Subjects will be given compensation for participation.in the form of an electronic -gift card sent via their 
email upon successful completion of the study procedures and return of the device 

STUDY QUALITY CONTROL AND QUALITY ASSURANCE

 Site Training
Effective Date: 1/22/2024
End Date:10/30/2024

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The Investigator is required to attend an Industry Collaborator’s training session which will be conducted 
at a site initiation visit or other appropriate training sessions. Training will include, but not be limited to 
the procedures with which to address subjects, the protocol plan, the completion of the various forms 
and the responsibilities of study staff. All Investigators or study staff that are trained must sign a Staff 
Training log. No Investigator or study staff will perform any study-related procedures prior to being 
trained and prior to signing a Staff Training log. 
At the initiation of the study, the Industry Collaborator or designee will visit the site where the study is 
conducted. The Industry Collaborator will ensure that clinical study staff are informed and understand the 
clinical study requirements. 

Compliance to Standards and Regulations
The Principal Investigator is responsible for obtaining and reviewing copies of IRB approvals, and ensuring 
that the study is conducted in compliance with the protocol, Code of Federal Regulations, the Declaration 
of Helsinki and applicable local regulatory requirements, ensuring proper clinical site monitoring and 
ensuring subject informed consent is obtained. 
The Investigator shall ensure that all work and services described herein shall be conducted in accordance 
with the highest standards of medical and clinical research practice. The Investigator will provide copies 
of the protocol to all co-Investigators or other staff responsible for study conduct. 
The Investigator shall ensure that all serious adverse events will be reported to the Institutional Review 
Board and Industry Collaborator within 24 hours. 
Regulatory documentation includes those documents that must be submitted, reviewed and approved by 
the Institutional Review Board before subject enrollment can begin at the clinical site. These documents 
function to demonstrate compliance of the Investigator and Industry Collaborator with regulatory 
requirements. 

 Quality Assurance Audit
In the event that an Investigator is contacted by a Regulatory Agency in relation to this study, the 
Investigator will notify the Industry Collaborator immediately.  The Investigator or his designee must be 
available to respond to reasonable requests and audit queries made during an audit process. The 
Investigator must provide the Industry Collaborator with copies of all correspondence that may affect the 
review of the current study (e.g., Form FDA 483, Inspectional Observations, and warning letters). 

PUBLICATION POLICY
The data and results from this study will be co-owned by the Investigator and the Industry Collaborator. 
The Investigator is free to communicate and/or publish with respect to the Study being conducted 
hereunder with prior approval of Industry Collaborator.  The Investigator agrees to submit to Industry 
Collaborator the proposed publication at least thirty (30) days prior to the submission thereof for 
publication.  The purpose for such prior submission is to identify any Confidential Information to be 
deleted from the proposed publication and to solicit collaborative feedback on the manuscript.  At the 
end of the thirty (30) day period, the Investigator shall be free to proceed with publication if consent from 
the Industry Collaborator has been granted. The Investigator and Industry Collaborator are bound by the 
terms outlined within the Investigator-Initiated Clinical Trial Agreement.
Effective Date: 1/22/2024
End Date:10/30/2024

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
ClinicalTrials.org Registration
The Investigator will register study with the https://www.Clinicaltrials.gov website, a public clinical trials 
registry, in accordance with applicable laws and regulations. A description of this study and summary of 
the results of this study will be included on this website. This Web site will not include patient 
identifiable information.  

CONFIDENTIALITY
Neither the Investigator nor the Industry Collaborator will release the subject’s private and personal 
information.
This study protocol, documentation data, and all other information generated, will be held in strict 
confidence by the Investigator and their representatives. No information concerning the study or the data 
will be released to any unauthorized third party without prior written approval by the Industry 
Collaborator.
No subject names, medical record numbers, or other personally identifying information will be used as 
part of the study.  Data Collection forms will not contain confidential information linking the outcome 
result to a subject.  Only the study site will have the information that links a subject to his/her identifying 
information.  Subjects will only be referred to by using their unique Subject ID number.
Effective Date: 1/22/2024
End Date:10/30/2024