Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
Phase: NA
Conditions: Cystic Fibrosis, Bronchiectasis
Sponsor: International Biophysics Corporation

1 
 
AffloVest Comparative Study for Air Flow in the Lungs 
 
Sponsor:  
 
 
International Biophysics Corporation 
 
 
 
 
2101 E. St. Elmo Rd Suite 275, Austin, TX 78744 USA 
512-814-0046 
Geoff Marcek, VP Engineering and Quality 
 
Monitor: 
 
 
Same as sponsor 
Medical Expert: 
 
N/A 
 
Investigators:  
 
Thomas William O’Brien, MD 
 
 
 
 
1121 N. Central Avenue 
 
 
 
 
Kissimmee, FL 34741 
 
 
 
 
407-624-4831 
 
 
 
 
Clinical Laboratory(ies): 
N/A 
 
 
 
 
Study Product:  
 
International Biophysics AffloVest 
 
 
 
 
Hill-Rom The Vest 
 
 
 
 
Electromed SmartVest 
 
 
 
 
Respirtech inCourage 
 
Protocol Number: 
 
2017-02 
 
 
 
 
Initial version date: 01/25/2018 
 
 
 
 
Amendment #: 1 
Amended date: 04/18/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
Table of Contents 
 
Study Summary 
 
1. Introduction 
1.1 Background 
1.2 Investigational or Study Product 
1.3 Preclinical Data 
1.4 Clinical Data to Date 
1.5 Dose Rationale  
1.6 Risks/Benefits 
2. Study Objectives 
3. Study Design 
3.1 General Design 
3.2 Primary/Secondary Study Endpoints 
4. Subject Selection and Withdrawal 
      4.1 Inclusion Criteria 
      4.2 Exclusion Criteria 
      4.3 Subject Recruitment and Screening 
      4.4 Early Withdrawal of Subjects 
       5. Investigational Product 
 
      5.1 Description 
 
      5.2 Treatment Regimen 
 
      5.3 Method for Assigning Subjects to Treatment Groups 
 
      5.4 Subject Compliance Monitoring  
 
      5.5 Prior and Concomitant Therapy  
 
      5.6 Packaging, Receiving, Storage, Dispensing and Return  
        6.   Study Procedures 
        7.   Statistical Plan 
 
     7.1 Sample Size Determination 
 
     7.2 Statistical Methods 
 
     7.3 Subject Population(s) for Analysis 
        8.  Safety and Adverse Events 
 
     8.1 Definitions 
 
     8.2 Assessment of Safety and Efficacy  
 
     8.3 Recording and Reporting of Adverse Events 
 
     8.4 Unblinding Procedures 
 
     8.5 Stopping Rules 
 
     8.6 Medical Monitoring 
 
     8.7 Study-Related Injuries 
        9.  Data Handling and Record Keeping 
 
     9.1 Confidentiality 
 
     9.2 Source Documents 
 
     9.3 Records Retention 
       10.  
Study Monitoring, Auditing, and Inspecting 
       11.  
Ethical Considerations 
 
 

3 
 
List of Abbreviations 
 
    
 
IBC – International Biophysics Corporation 
 
HFCWO – High Frequency Chest Wall Oscillation 
 
FEV1 – Forced Expiratory Volume is the volume (L) of air measured in the first one (1) second of 
the FVC test 
 
FVC – Forced Vital Capacity shows the volume (L) of air a person can forcefully and quickly 
exhale after taking a deep breath 
 
PEF – Peak Expiratory Flow shows the maximum airflow (L/min) during a forced expiration 
beginning with the lungs fully inflated 
 
TV – Tidal Volume describes the volume (L) representing the normal volume of air displaced 
between normal inhalation and exhalation when extra effort is not applied 
 
FEF25 – 75% - The mean forced expiratory flow (L/s) over the interval from 25% to 75% remaining 
of the Forced Vital Capacity 

4 
 
STUDY SUMMARY 
Title 
AffloVest Comparative Study for Air Flow in the Lungs 
Protocol Number 
PROTO2017-02 
Phase 
Device, Phase I 
Methodology 
The study will be broken into three (3) arms: 
- 
AffloVest® & The Vest® 
- 
AffloVest® & inCourage® 
- 
AffloVest® & SmartVest® 
Subjects will be randomly assigned to an arm. Within each arm, the order of 
products will be also randomized. 
Baseline spirometry (FEV1, FVC, PEF, FEF25-75% and TV) will be taken at 
the beginning, middle and end of each subject trial without any device on the 
subject. 
A product (AffloVest or Air-Bladder type vest) will be placed onto subject and 
turned ON to the highest frequency and intensity settings, then the subject will 
be given a certain period of time. The spirometry measurements will then be 
repeated. The product will be removed and the subject allowed a recovery 
period, then the other product will be placed on the subject, turned ON and 
spirometry measurements repeated. A short questionnaire will also be 
included. 
Study Duration 
Approximately one (1) month  
Study Center(s) 
Pulmonary Disease Specialists, PA (d/b/a PDS Research) 
1121 N. Central Avenue 
Kissimmee, FL 34741
Objectives 
Investigate impact of high-frequency chest wall oscillation therapy on 
spirometry values (FEV1, FVC, PEF, FEF25-75% and TV) during use of 
several products and comparing to baseline values to determine any 
significant variation in air flow in the lungs. 
Number of subjects 
30 (10 subjects per arm) 
Main Inclusion and 
Exclusion Criteria 
Inclusion: Healthy subject, ages 18 – 50 
Exclusion: Non-ambulatory, diagnosed neuromuscular disorder, currently 
using any type of oscillation vest therapy, diagnosed co-morbid condition (i.e. 
lung cancer, other lung disorder or disease), currently enrolled in a medical 
research study, non-English speaking 
Study product, Dose, 
Route, Regimen 
The International Biophysics AffloVest®, Hill-Rom The Vest®, Respirtech 
inCourage® and Electromed SmartVest® will be included in the study. The 
Hill-Rom Monarch™ was originally planned to be included in the study, 
however due to recent FDA recall the product could not be obtained for 
testing.1 
Each subject will be properly fitted with a product and then the product will be 
turned ON. The subject will wear the product for a brief time before taking 
spirometry readings. The subject will then switch to a different product after a 
recovery period and the procedure will be repeated. Each subject will then be 
asked to fill out a short questionnaire. 
Duration of subjects 
One (1) day, approximately two (2) hours per subject 
                                                           
1 FDA Recall Database, Recall Number Z-0192-2018. 

5 
 
participation  

6 
 
1 
Introduction 
This document is a clinical research protocol and the study will be conducted in accordance with 
this protocol. The study will be conducted in accordance with Good Clinical Practice Standards 
and all applicable regulatory requirements. 
 
1.1 Background 
High Frequency Chest Wall Oscillation (HFCWO) is a therapy that has been proven to be 
effective for many years2 and is used for airway clearance for patients that have difficulty 
mobilizing secretions in the lungs.  One method to accomplish HFCWO therapy utilizes air 
bladder compression of the torso to create oscillation in the lungs.   Air bladder companies claim 
“The assumption is that the effectiveness of the treatment can be measured in the mouth airflow 
which is believed to be the indicator of the efficacy of the therapy”3. Air bladder devices claim that 
they create air shearing forces in the lungs by increasing air flow in the lungs by shaking and 
compressing the entire torso to supposedly generate airflow in the lungs to mobilize secretions.  
Moreover, air bladder companies have claimed that they create more air flow in the lungs then 
the newer oscillation technology4. The purpose of this study is to measure and compare airflow 
actually in the lungs while using both air bladder and motorized oscillation HFCWO technology to 
determine the actual air flow in the lungs.  Lung airflow will be measured using standard 
pulmonary spirometry clinical equipment. The results will be collected and analyzed. 
 
1.2 Investigational/Study Product 
The devices under study are all High-Frequency Chest Wall Oscillation (HFCWO) devices which 
are summarized in the following table. All these devices are Class II medical devices in the USA 
with 510(k) clearance from FDA. 
 
Table 1 – Study Product 
Manufacturer and 
Brand 
510(k) 
Number 
Indications for Use 
International 
Biophysics 
Corporation AffloVest 
K122480 
“The International Biophysics Corporation AffloVest is intended for 
promoting airway clearance and improvement of bronchial drainage 
by enhancing mobilization of bronchial secretions where external 
manipulation of the thorax is the physician’s choice of treatment”
Hill-Rom The Vest® 
Model 105 
K142482 
“The Vest® Airway Clearance Systems is intended to provide airway 
clearance therapy when external manipulation of the thorax is the 
physician’s choice or treatment. Indications for this form of therapy 
are described by the American Association of Respiratory Care 
(AARC) in the Clinical Practices Guidelines for Postural Drainage 
Therapy. According to AARC guidelines, specific indications for 
external manipulation of the thorax include evidence or a suggestion 
of retained secretions, evidence that the patient is having difficulty 
with the secretion clearance, or presence of atelectasis caused by 
mucus plugging. In addition, the Vest® Airway Clearance System is 
also indicated for external manipulation of the thorax to promote 
airway clearance or improve bronchial drainage for the purposes of 
collecting mucus for diagnostic evaluation.” 
Electromed 
SmartVest® System 
K132794 
"The Smart Vest® Airway Clearance System, Model SQL is 
designed to deliver high-frequency chest wall oscillation to promote 
                                                           
2 Warwick et al 1991 Pediatric Pulmonology 
3 Analysis of High Frequency Chest Compression Devices and Modeling. A DISSERTATION SUBMITTED TO THE FACULTY OF THE 
GRADUATE SCHOOL OF THE UNIVERSITY OF MINNESOTA BY Yong Wan Lee IN PARTIAL FULFILLMENT OF THE 
REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY/ELETRICAL ENGINEERING Bruce F. Wollenberg, 
Thomas J. O'Dea December 2007 
4 Independent lab testing analyzed and compared average airflows at the mouth generated by high frequency chest wall oscillation 
(HFCWO) therapy in 10 subjects using home care garments Airflows measured at commonly prescribed medium pressures (50% of 
maximum) at multiple therapy frequencies (5, 10, 15, and 20 Hz). Test data and reports on file at Hill-Rom, Inc 

7 
 
Manufacturer and 
Brand 
510(k) 
Number 
Indications for Use 
airway clearance and improve bronchial drainage. The Smart Vest 
System is indicated when external chest manipulation is the 
physician's treatment of choice to enhance mucus transport."
Respirtech 
inCourage™ System 
K051383 
The inCourage TM System is indicated when external manipulation 
of the chest is the physician's treatment of choice for increasing the 
clearance of mucus in patients with pulmonary disorders. The 
system promotes airway clearance and improves bronchial drainage 
utilizing High Frequency Chest Wall Oscillation (HFCWO).
 
The devices are similar in intended use, but different in mode of operation. The Hill-Rom The 
Vest, Electromed SmartVest and Respirtech inCourage use an air bladder system which 
connects to an inflatable bladder worn by the subject. The International Biophysics AffloVest uses 
vibratory motors sewn into the vest to mobilize secretions.  
 
Patients are prescribed these types product by a physician, along with the treatment regimen. 
 
 1.3 Preclinical Data 
 
Preclinical studies of the AffloVest product have been performed by IBC to demonstrate 
substantial equivalence of the device to other similar devices (predicates). The preclinical studies 
including electrical safety and EMC testing, testing for compliance with home-healthcare 
standards for electrically powered devices, human factors and usability testing, software 
validation and system verification testing. 
 
Preclinical data has been gathered by the other products but is confidential to those 
manufacturers. A summary of the preclinical test data is included in the 510(k) summary for each 
device.  
 
Preclinical data regarding these devices is not expected to have clinical significance nor 
relevance to this trial. 
 
1.4 Clinical Data to Date 
 
There is no clinical data to date regarding the spirometry measurements to be taken in this study. 
 
 
There are no known potential risks to subjects using the AffloVest. The product has been 
marketed since 2014 with zero (0) adverse events reported in that timeframe. 
 
IBC does not have any adverse event data on the competitor products, but these types of devices 
are widely regarded as safe. 
 
 
The study provides no foreseeable benefits to the subjects. 
 
1.5 Dose Rationale  
 
These devices are typically prescribed to be used daily for 20 – 30 minutes one (1) or two (2) 
times daily at home. 
 
 
The devices settings have been specified as the highest intensity and frequency for each device 
to ensure consistency across all devices. The approach taken will simulate spirometry values for 
patients during normal use of these products. 
 
1.6 Risk/Benefits 
 
This study poses no foreseeable risk to the subjects. The study provides no foreseeable benefits 
to the subject. These devices are generally considered safe with low incidence of adverse events 
in normal use. The study activities are not expected to impart greater than minimal risk to the 
subjects. 

8 
 
 
All data collected will remain confidential. Only the investigators involved with this study will have 
access to it. In order to maintain confidentiality, all records will be kept in locked filing cabinet(s) 
at the investigator site(s). If the results of the study are published, the data will be reported 
collectively without mention of any subject’s identity, thereby ensuring subject anonymity. 
 
2  Study Objectives 
The purpose of this trial is to investigate the potential relationship between the use of common 
HFCWO devices to measure air flow in the lungs in healthy subjects using standard spirometry 
techniques. 
 
3 
Study Design 
3.1  General Design 
 
This pilot study has been designed as follows: 
 
• 
Three (3) arms 
• 
This is a pilot investigational study, based on the study design there are no blinding or 
randomization measures taken. It is expected that the degree of bias shall be low based 
on the subjective endpoints under study. Each subject shall serve as their own control as 
baseline spirometry measurements will be performed at the beginning and end of the 
visit. 
• 
Each subject will participate for a period of approximately two (2) hours. 
• 
There is no subject follow-up, all measurements will be performed within the initial subject 
visit. At the end of the visit, each subject shall be required to complete a brief survey 
regarding their experience. 
 
3.2 Primary/Secondary Endpoints 
 
The following primary and secondary endpoints are to be analyzed in the study: 
 
 
Primary endpoints: 
 
1. Difference in spirometry measurements (FEV1, FVC, PEF, FEF25-75% and TV) between the 
AffloVest device and air-bladder type devices. 
 
Secondary endpoints: 
 
1. Survey results using a Likert scale related to: 
a. Subject opinion on using each device on a daily basis 
b. Subject opinion on lifestyle fit for each device 
c. Subject opinion on lifestyle obtrusiveness of each device 
d. Subject opinion on mobility during use of each device 
e. Subject opinion on noise level of each device 
f. 
Subject opinion on compliance with treatment of each device 

9 
 
4 
Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
 
The following subjects shall be eligible for study enrollment: 
 
1. Healthy subject, ages 18 – 50 
 
 
        4.2 Exclusion Criteria 
 
The following subjects shall be ineligible for study enrollment: 
 
1. Non-ambulatory 
2. Diagnosed neuromuscular disorder 
3. Currently using any type of oscillation vest therapy 
4. Diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease) 
5. Currently enrolled in a medical research study 
6. Non-English speaking 
 
        4.3 Subject Recruitment and Screening 
Subjects will be recruited in accordance with the investigator standard operating procedure (SOP) 
for subject recruitment. 
 
Based on the small number of subjects required and short study duration, it is expected that the 
following methods will be used for subject recruitment: 
 
• 
Internet/company website 
• 
Private practice database 
 
Subjects will be screened by the investigator according to the standard operating procedure 
(SOP) in place at the investigator’s site. 
 
4.4 Early Withdrawal of Subjects  
Subjects may choose to withdraw from the study at any time, for any reason without penalty or 
loss of benefit. 
 
Due to the short duration of the subject participation in the study, there is only one (1) foreseeable 
scenario in which a subject could withdraw prior to completion of the study: 
 
• 
A subject might withdraw from the subject if use of the device(s) is uncomfortable. Some 
patients could be claustrophobic and find the treatment uncomfortable. 
 
For any subject that withdraws prior to completion of the study for this reason, the data will be 
omitted from the final analysis. The subject may be replaced with another subject to ensure that 
the full sample size is obtained. 
 
Abrupt termination of study treatment is not expected to affect subject safety, therefore no 
transition procedures are required. 
 
5     Investigational Product  
5.1 Description  
AffloVest Oscillation Vest - The product is a home-use device and appears as a wearable vest 
with accessories (i.e. battery, A/C power supply, etc.) 
 
Hill-Rom The Vest – The product is a home-use device and appears as a wearable vest with 
generator and hoses. 
 
Electromed SmartVest – The product is a home-use device and appears as a wearable vest with 
generator and hoses. 

10 
 
 
Respirtech inCourage – The product is a home-use device and appears as a wearable vest with 
generator and hoses. 
 
5.2 Treatment/Dosing Regimen 
 
Each subject shall perform the following regimen: 
 
1. Pre-baseline spirometry measurements (without device on patient) 
2. Placement of either AffloVest or air-bladder type product on subject, turn device ON, allow 
subject to acclimate to device for five (5) minutes 
a. Repeat spirometry measurements 
3. Remove device from subject and allow subject to recover for fifteen (15) minutes 
4. Interim-baseline spirometry measurements (without device on patient) 
5. Placement of other product (either AffloVest or air-bladder type product, whichever was not 
used previously) on subject, turn device ON, allow subject to acclimate to device for five (5) 
minutes 
a. Repeat spirometry measurements 
6. Remove device from subject and allow subject to recover for fifteen (15) minutes 
7. Post-baseline spirometry measurements (without device on patient) 
 
        5.3 Method for Assigning Subjects to Treatment/Dosing Groups 
Subjects shall be assigned according to the following in order of study enrollment. This approach 
shall control for any effect from which device is used first by alternating the device order. 
Subject Number 
First Device 
Second Device 
1 
AffloVest
Hill-Rom The Vest
2 
Hill-Rom The Vest
AffloVest 
3 
AffloVest
Hill-Rom The Vest
4 
Hill-Rom The Vest
AffloVest 
5 
AffloVest
Hill-Rom The Vest
6 
Hill-Rom The Vest
AffloVest 
7 
AffloVest
Hill-Rom The Vest
8 
Hill-Rom The Vest
AffloVest 
9 
AffloVest
Hill-Rom The Vest
10 
Hill-Rom The Vest
AffloVest 
11 
AffloVest
Electromed SmartVest
12 
Electromed SmartVest
AffloVest 
13 
AffloVest
Electromed SmartVest
14 
Electromed SmartVest
AffloVest 
15 
AffloVest
Electromed SmartVest
16 
Electromed SmartVest
AffloVest 
17 
AffloVest
Electromed SmartVest
18 
Electromed SmartVest
AffloVest 
19 
AffloVest
Electromed SmartVest
20 
Electromed SmartVest
AffloVest 
21 
AffloVest
Respirtech inCourage
22 
Respirtech inCourage
AffloVest 
23 
AffloVest
Respirtech inCourage
24 
Respirtech inCourage
AffloVest 
25 
AffloVest
Respirtech inCourage
26 
Respirtech inCourage
AffloVest 
27 
AffloVest
Respirtech inCourage
28 
Respirtech inCourage
AffloVest 
29 
AffloVest
Respirtech inCourage
30 
Respirtech inCourage
AffloVest 

11 
 
 
        5.4 Subject Compliance Monitoring  
 
No compliance monitoring shall be required for this trial, it is expected that each subject shall 
participate for approximately 1 – 2 hours with no further follow-up required. 
       
        5.5 Prior and Concomitant Therapy  
There are no restrictions regarding medication(s) and/or treatments before and/or after the trial.  
 

12 
 
 5.6 Packaging, Receiving, Storage, Dispensing and Return 
The devices will be shipped to the investigator in standard packaging and standard storage 
procedures shall be employed. The devices will be kept in a secured area. 
 
At the completion of the study, all devices will be returned to the sponsor. 
 
6 
Study Procedures 
The study procedure shall be broken down into several phases, as described below: 
 
1. Phase 1 – Subject enrollment 
 
• 
Subjects shall be enrolled based on the plan presented previously in the protocol. 
Informed consent will be required from each subject. 
• 
General demographic data information (age, gender, race, ethnicity, height, weight, 
comorbidities) will be collected for each subject. 
 
2. Phase 2 – Initial Spirometry measurements 
 
• 
After subject enrollment, the subject will be fitted with both an AffloVest product and 
the appropriate air-bladder type vest. 
• 
An initial spirometry baseline will be taken using standard spirometry equipment and 
according to standard spirometry procedures, without any device on the subject. 
• 
Depending on the subject enrollment number, the appropriate product will be placed 
onto the subject. 
• 
The device will be turned on to the maximum frequency and intensity settings. 
• 
The subject will be allowed five (5) minutes to acclimate to the device. 
• 
The spirometry measurements will then be repeated in the same manner as above 
• 
The device will be turned OFF and removed, and the subject will be allowed fifteen 
(15) minutes recovery 
• 
An interim spirometry baseline will be taken using standard spirometry equipment 
and according to standard spirometry procedures, without any device on the subject. 
• 
Depending on the subject enrollment number, the second appropriate product will be 
placed onto the subject. 
• 
The device will be turned on to the maximum frequency and intensity settings. 
• 
The subject will be allowed five (5) minutes to acclimate to the device. 
• 
The spirometry measurements will then be repeated in the same manner as above 
• 
The device will be turned OFF and removed, and the subject will be allowed fifteen 
(15) minutes recovery 
• 
A final spirometry baseline will be taken using standard spirometry equipment and 
according to standard spirometry procedures, without any device on the subject 
 
3. Phase 3 – Survey 
 
• 
The subject will be provided a brief survey to complete 
 
No interim analysis shall be completed. 
 
        7 Statistical Procedures 
        7.1 Sample Size Determination 
This is a pilot investigational trial. No statistical analysis was performed in the generation of the 
sample size, however similar studies for these types of devices were reviewed to determine an 
adequate sample size. 
 
 
   7.2 Statistical Methods 
The metrics for the study shall be calculated as follows: 

13 
 
 
- 
Subject baseline values: An average of the pre-baseline, interim-baseline and post-
baseline measurements shall be taken for FEV1, FVC, PEF, FEF25-75% and TV for 
each subject 
- 
Comparison of the subject baseline values will be made with their values while using 
each device. A Student’s t-test will be used to look for statistically significant differences 
at the 95% confidence level 
 
Any deviation(s) from the original statistical plan shall be communicated to the IRB and the 
protocol shall be revised, if required.  
 
 
   7.3 Subject Population(s) for Analysis 
 
 
All eligible subjects shall be included in the analysis. 
 
         8 Safety and Adverse Events 
         8.1 Definitions 
 
The study shall be monitored for Unanticipated Problems and for Adverse Events by the 
investigator and sponsor. 
 
An Unanticipated Problem shall be defined as: 
• 
Any issue arising during the study involving potential risk(s) to the subjects, which are not 
considered adverse events. 
• 
Unanticipated Problems shall be reported to the IRB and sponsor within 7 calendar days, 
unless as described below: 
o 
Interim analysis, safety monitoring report, publication in literature or other 
information that indicates an increase in the frequency or magnitude of a given 
harm, uncovers a new risk, or provides more information about the benefits of the 
human research. 
o 
Change in FDA labeling or withdrawal of the device from the market 
o 
Protocol deviation that harmed participants or indicates participants might be at 
increased risk of harm. If the protocol deviation was made in order to eliminate an 
apparent immediate hazard to a participant, the investigator must submit the 
information to the IRB and sponsor within 24 hours. 
o 
Complaint of a participant that indicates participants or others might be at increased 
risk of harm or at risk of a new harm. 
o 
Finding of Non-Compliance or allegation of Non-Compliance. 
o 
Protocol deviations: Failure to follow the protocol due to the action or the inaction of 
the investigator or staff. Exception – If the protocol deviation was taken in order to 
eliminate an apparent immediate hazard to the participant, the investigator must 
report the information to the IRB and sponsor within 24 hours. 
o 
Breach of confidentiality – Must be reported to IRB and sponsor within 24 hours 
o 
Change to protocol taken without prior IRB review to eliminate an apparent 
immediate hazard to a participant, must be reported within 24 hours 
o 
Incarceration of a participant in a protocol not approved to enroll prisoners 
o 
Complaint of a participant that cannot be resolved by the research team 
 
An Adverse Event shall be defined per 21 CFR Part 803. Any potential adverse event shall be 
reported to the IRB and sponsor within 7 calendar days, unless the Adverse Event could be 
considered reportable as a 5-day report, in which case the notification must be made within 24 
hours. 
 
• 
An event that reasonably suggests that a device has or may have caused or contributed 
to a death or serious injury 
• 
An event that reasonably suggests that a device has malfunctioned and that the device or 
similar device would be likely to cause or contribute to a death or serious injury if the 
malfunction were to recur 

14 
 
• 
A serious injury/serious illness is one that (1) is life threatening, (2) results in permanent 
impairment of a body function or permanent damage to body structure, or (3) 
necessitates medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 
 
 
    8.2 Recording and Reporting of Adverse Events 
All observed or volunteered adverse events, unanticipated problems involving risks to subjects, 
and serious or continuing noncompliance with the federal regulations or the requirements or 
determinations of the IRB will be reported. Investigators will pursue and obtain information 
adequate to determine the outcome of each adverse event and to assess whether it meets the 
criteria for classification as a serious adverse event requiring immediate notification to the 
sponsor, Investigational Review Board and FDA. Sufficient information will be obtained by the 
investigator to determine and assess the causality of adverse event. This study will be reviewed 
at set checkpoints, as specified in the research plan, by the principal investigators. 
The sponsor has a duty to report adverse events to FDA per 21 CFR Part 803 and maintains 
SOP’s detailing these requirements. Any adverse event reported to FDA by the sponsor related to 
a study subject will also be transmitted to the IRB. 
 
    8.4 Randomization Codes and Unblinding Procedures 
There are no randomization and/or blinding procedures in this trial.  
 
 
 8.5 Stopping Rules 
After any Unanticipated Problem and/or Adverse Event, a review shall be performed to 
determine whether the study should be terminated for individual subject(s), parts or all of the 
trial. This shall be determined by the investigator. 
 
 
 8.6 Medical Monitoring 
 
No additional medical monitoring shall be performed throughout the duration of study. 
 
         
 
8.7 Study-Related Injuries 
 
Adverse events which are reported during execution of this study shall be handled and reported 
to relevant authorities in accordance with IBC’s internal standard operating procedures. 
 
 
IBC maintains suitable product liability insurance coverage in the event of any claims resulting 
from a study-related injury. 

15 
 
   
  9   Data Handling and Record Keeping 
 
  9.1 Confidentiality 
 
 
All data collected will remain confidential. Data will be stored securely under the subject’s study 
identification number. All clinical data, images and surgical/procedural data will be de-identified 
prior to any in-house or public presentation of data or images. Coded data will only be released to 
those listed as study investigators or support staff. Paper data records will be stored in locked file 
cabinets in a locked office. All electronic research data will be stored on a researcher database 
that is password protected and encrypted. The principal investigator, sub-investigators, IRB, the 
Food and Drug Administration and any applicable regulatory agencies will have access to the 
study records upon request. If the results of this study are published, the data will be reported 
collectively without mention of any subject’s identity, thereby ensuring subject anonymity. 
 
Standard confidentiality safeguards will be applied, including keeping paper records in locked 
files, use of electronic security processes (passwords, etc.) for access to electronic data, and 
limiting access of records to only personnel directly involved in the study 
 
 
  9.2 Source Documents 
The following documents shall be considered source documents: 
 
• 
Subject spirometry measurement data 
• 
Subject survey 
 
 
  9.4 Records Retention 
 
The data and associated identifiers will be kept for up to 5 years in a locked facility accessible 
only to designated personnel, at which time the data will be destroyed per investigator policy. 
 
 
10  Study Monitoring, Auditing, and Inspecting 
 
The study will be monitored on an ongoing basis by the investigator. Due to the short nature of 
the study, no periodic study monitoring, auditing and/or inspecting is planned. 
 
 
11  Ethical Considerations 
 
The Principal Investigator will manage and administer the study and ensure that the established 
procedures and protocol for protection of human subjects and IRB requirements are followed in 
compliance with the Federalwide Assurance for the Protection of Human Subjects, NIH, FDA and 
OHRP requirements. The principal investigator is an experienced researcher and maintains well-
established controls and policies for safeguarding subjects. International Biophysics Corporation 
also abides by written policies of clinical study ethics and patient protection.