Evaluation of the F&P Caramel Nasal Mask, US, 2023
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Fisher and Paykel Healthcare

I
Clinical Investigation Plan (CIP) 
Revision: A 
Parent Procedure: 
A 
Clinical Investigation Plan: F&P 
US, 2023 
Additional Notes: 
Not applicable 
Approval: 
;:-
1.2 
Fisher& Paykel 
HEALTHCARE 
Date
18 Oct 2023

 
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Table of Contents 
 
1. 
Clinical Trial Summary Information ........................................................................................................... 7 
2. 
Identification and Description of the Investigational Device ................................................................ 12 
3. 
Justification for the Design of the clinical investigation ...................................................................... 13 
3.1. 
Synopsis ....................................................................................................................................... 13 
3.2. 
Literature Review ......................................................................................................................... 13 
3.3. 
Pre-Clinical Testing ...................................................................................................................... 15 
3.4. 
Previous Clinical trial .................................................................................................................... 15 
3.5. 
Justification for Administration ..................................................................................................... 17 
4. 
Benefits and Risks of the investigational device, clinical procedure and clinical investigation ...... 17 
4.1. 
Anticipated benefits ...................................................................................................................... 17 
4.2. 
Risks associated with participation in the clinical investigation ................................................... 17 
4.3. 
Possible interactions with concomitant medical treatments ........................................................ 17 
4.4. 
Steps that will be taken to control or mitigate risks ...................................................................... 17 
4.5. 
Rationale for benefit-risk ratio ...................................................................................................... 17 
5. 
Objectives & Hypotheses of the clinical investigation .......................................................................... 18 
5.1. 
Objectives .................................................................................................................................... 18 
5.1.1. Patient participant objective. ................................................................................................... 18 
5.1.2. Partner participant objective ................................................................................................... 18 
5.2. 
Hypotheses .................................................................................................................................. 18 
5.2.1. Patient participant hypothesis  . .............................................................................................. 18 
5.2.2. Partner participant hypothesis ................................................................................................ 18 
5.3. 
Endpoints ..................................................................................................................................... 18 
5.3.1.1. 
Patient Participant Endpoints ............................................................................................ 18 
5.3.1.2. 
Partner Participant Endpoints ........................................................................................... 18 
5.4. 
Methods and Timing for assessing, recording and analysing variables ...................................... 20 
5.5. 
Equipment used for assessing clinical investigation variables and arrangements for monitoring 
maintenance and calibration ........................................................................................................ 21 
5.6. 
Procedures for the replacement of participants ........................................................................... 21 
5.7. 
Investigation sites ........................................................................................................................ 21 
5.7.1. Definition of completion of clinical investigation ..................................................................... 21 
5.8. 
Investigational device(s) and comparator(s) ................................................................................ 21 
6. 
Participants ................................................................................................................................................ 22 
6.1.1. Inclusion criteria for participants selection .............................................................................. 22 
6.1.2. Exclusion criteria for participants selection ............................................................................. 22 
6.1.3. Criteria and procedures for patients withdrawal / lost to follow-up ......................................... 23 
6.1.4. Point of Enrolment .................................................................................................................. 23 
6.1.5. Total expected duration of the clinical investigation ............................................................... 24 

 
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6.1.6. Expected duration of each participant .................................................................................... 24 
6.1.7. Number of subjects & Distribution of enrolment across sites ................................................. 24 
6.1.8. Estimated time to reach enrolment number ............................................................................ 24 
6.1.9. Information on vulnerable, pregnant / breastfeeding population (if applicable) ...................... 24 
7. 
Procedures ................................................................................................................................................. 24 
7.1.1. Clinical-Investigation Procedures ........................................................................................... 27 
7.2. 
Roles and Responsibilities ........................................................................................................... 30 
7.2.1. Activities performed by sponsor representatives .................................................................... 31 
7.2.2. Known / foreseeable factors affecting clinical investigation outcome or interpretation of 
results ..................................................................................................................................... 31 
7.2.3. Methods for addressing known / foreseeable factors ............................................................. 32 
7.2.4. Follow-up period during clinical investigation ......................................................................... 32 
7.2.5. Medical care for participants after completion of clinical investigation ................................... 32 
7.3. 
Monitoring Plan ............................................................................................................................ 32 
8. 
Statistical Design and Analysis ............................................................................................................... 35 
8.1. 
Data Collection ............................................................................................................................. 35 
8.1.1. Safety Data ............................................................................................................................. 36 
8.2. 
Sample size calculation and justification ..................................................................................... 36 
8.3. 
Pass / Fail Criteria ........................................................................................................................ 36 
8.4. 
Management of Controls and Bias .............................................................................................. 37 
8.5. 
Unused or spurious data (including drop-outs) management ...................................................... 38 
9. 
Data Management ...................................................................................................................................... 38 
9.1. 
Methods (e.g. CRF) for data entry and collection ........................................................................ 38 
9.2. 
Procedures used for handling CRF data ..................................................................................... 38 
9.3. 
Procedures for verification, validation and securing of electronic data systems (if applicable) ... 38 
9.4. 
Procedures to maintain and protect participant privacy ............................................................... 38 
9.5. 
Methods for database locking (start of analysis and storage) upon completion of clinical 
investigation ................................................................................................................................. 38 
9.6. 
Procedures for data retention ...................................................................................................... 38 
9.7. 
Specified retention period ............................................................................................................ 39 
9.8. 
Other aspects of clinical quality assurance (As appropriate) ....................................................... 39 
10. 
Amendments to the CIP ............................................................................................................................ 39 
11. 
Deviations from clinical investigation plan (CIP) ................................................................................... 39 
11.1. Exceptions that allow deviations to the CIP ................................................................................. 39 
11.2. Procedures for recording, reporting and analysing CIP deviations ............................................. 39 
11.3. Notification requirements and time-frames .................................................................................. 39 
12. 
Device Accountability ............................................................................................................................... 40 
12.1. Description of procedures for accountability of investigational devices ...................................... 40 
12.2. Procedures for the return of investigational devices .................................................................... 40 

 
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13. 
Statements of Compliance ....................................................................................................................... 40 
13.1. Conducting the investigation in accordance with the Declaration of Helsinki .............................. 40 
13.2. Conducting this clinical investigation in compliance with regional or national regulations .......... 40 
13.3. Approval / Favourable opinion from the EC / Regulatory authority ............................................. 41 
13.4. Additional requirements imposed by the EC / Regulatory authority ............................................ 41 
13.5. Insurance for subjects .................................................................................................................. 41 
13.6. Financing of the clinical investigation .......................................................................................... 41 
14. 
Informed Consent Process ....................................................................................................................... 41 
14.1. General process for obtaining informed consent ......................................................................... 41 
14.2. Circumstances where informed consent cannot be gained ......................................................... 41 
15. 
Adverse Events, Adverse device effects and device deficiencies ....................................................... 42 
15.1. List of non-reportable events ....................................................................................................... 42 
15.2. Time period of reporting AEs & ADEs ......................................................................................... 43 
15.3. Process for reporting AEs ............................................................................................................ 43 
15.4. Process of reporting DDs ............................................................................................................. 43 
15.5. Emergency contact details for reporting SAEs and SADEs ........................................................ 43 
16. 
Suspension or premature termination of clinical investigation ........................................................... 44 
16.1. Criteria and arrangements for suspension or premature termination .......................................... 44 
16.2. Criteria to assess and to break blinding/masking code ............................................................... 44 
16.3. Requirements for  follow-up and continued care ......................................................................... 44 
17. 
Publication Policy ..................................................................................................................................... 45 
17.1. Registration of clinical investigation in a publicly accessible database ....................................... 45 
17.2. Availability of clinical investigation results    . .............................................................................. 45 
18. 
Regulatory and Other References ........................................................................................................... 45 
18.1. Internal References ...................................................................................................................... 45 
18.2. External References .................................................................................................................... 45 
18.3. Bibliography ................................................................................................................................. 47 
19. 
Revision history......................................................................................................................................... 48 
20. 
Appendix A –
 
 
 
 
 
 
 
 
 
 
 
   
 
 

 
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The interface should provide an effective seal over the face to minimize leak, a factor which significantly 
impacts the sleep quality and level of comfort experienced by patients, as well as their long-term tolerance 
and adherence to treatment3,13. While there are a significant number of benefits to using PAP and NIV 
therapies for the relevant indications, both also come with some risks to the patient. These include potential 
sleep disruption, facial irritation, mandibular pain, internal trauma, anxiety sensitivity, abdominal discomfort, 
physiological compromise, facial discomfort, facial dryness, mucosal congestion, and facial inflammation. 
However, manufactures of medical devices which deliver PAP and NIV therapies can address a number of 
these side effects with improving design and functionality. This may involve the incorporation of 
humidification and ER technologies in machines, or the use of comfortable and non-irritating materials for 
interfaces 
3.3. 
Pre-Clinical Testing 
PAP therapy is a treatment designed to be administered to humans.  
 
 
 
 
 
 
 
 
 
a series of bench tests is conducted on the investigational 
product to ensure it is safe and will perform as expected when used on human subjects.  
 
 
3.4. 
Previous Clinical trial 
The main objective of the F&P 
mask is to develop a 
 
. The F&P 
 
  
The F&P 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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5. 
Objectives & Hypotheses of the clinical investigation 
 
5.1. 
Objectives 
5.1.1. Patient participant objective 
To evaluate the performance, comfort, usability, stability, and reliability of the F&P 
 mask among 
participants using PAP therapy, with regards to participant views on overall experience, satisfaction, and 
acceptance. 
 
 
 
 
 
5.2. 
Hypotheses 
5.2.1. Patient participant hypothesis 
 
Primary hypothesis: The F&P 
 mask is effective in providing adequate PAP therapy, or treatment 
comparable to that provided by the usual mask used by participants, for managing a respiratory condition during 
in-home use. 
 
Secondary hypothesis: The F&P 
 mask presents an acceptable safety profile when used by 
participants with PAP therapy for the management of a respiratory condition during in-home use. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

 
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5.4. 
Methods and Timing for assessing, recording and analysing variables 

 
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6. 
Participants 
6.1.1. Inclusion criteria for participants selection 
F&P 
 following inclusion and exclusion criteria.  
Inclusion criteria for patient participant: 
• 
Persons who are ≥22 years of age 
• 
Persons who weigh ≥66 pounds (or 30 kg) 
• 
Persons who have been prescribed PAP therapy by a physician 
• 
Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment 
in the clinical trial 
• 
Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day 
period within 30 days prior to enrolment in the clinical trial 
• 
Persons who are fluent in spoken and written English 
• 
Persons who possess the capacity to provide informed consent 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
6.1.2. Exclusion criteria for participants selection 
Exclusion criteria for patient participant: 
• 
Persons who are intolerant to PAP therapy 
• 
Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy 
inappropriate 

 
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• 
Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not 
including sleep or naps 
• 
Persons who are trying to get pregnant, are pregnant, or think they may be pregnant 
• 
Persons who have an IPAP pressure of >30 cmH2O if on BPAP 
• 
Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen 
• 
Persons who use a PAP therapy device that does not possess data recording capabilities to capture 
AHI and a numerical indicator of leak that is accessible to the investigation site 
 
  
 
 
 
 
 
6.1.3. Criteria and procedures for patients withdrawal / lost to follow-up 
Participants will be informed that they have the right to withdraw from the clinical investigation at any time, 
without prejudice or compromise to their medical care, and are not obliged to state their reasons.  
 
 
 
 
 
 
 
 
 
 
 
The PI may withdraw a participant at any time for the following reasons: 
• 
Protocol violation 
• 
Safety concerns 
• 
Serious illness 
• 
AEs 
 
 
  
 
 
6.1.4. Point of Enrolment 
 
 
 
 
.  
 
 
 
 
 
 
 
 
 

 
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7.1.1. Clinical-Investigation Procedures 
 
Details of the key events that will occur during the F&P N
 
 
A. Recruitment 
 
 
  
 
  
 
 
 
 
  
 
  
 
. 
 
The following will take place during recruitment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
B. 
 
 
  
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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C. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
D. 
 
 
 
 
 
Procedures that will be carried out 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
E. 
 
 
 
 
 
Below are the activities
 
 
 
 

 
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F. 
 
  
 
 
 
Below are the activities 
 
 
 
 
 
 
. 
 
G. 
 
 
 
 
 
 
Below are the activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
H. 
 
 
 
 
Procedures that will be carried out 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Details of the key events that will occur 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.2. 
Roles and Responsibilities 

 
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. 
 
 
 
 
 
 
 
 
 
 
 
 

 
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7.2.4. Follow-up period during clinical investigation 
Participants will be monitored for the duration of their enrolment in the clinical investigation 
 
 
 
ational product arising.  Moreover, the clinical investigation may be terminated if 
progress is unsatisfactory. 
 
The following is required 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.3. 
Monitoring Plan 
Fisher & Paykel Healthcare (F&P) will appoint 
 
 

 
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Responsibilities 
 
 
 
 
  
Specific tasks include: 
 
 
 
  

 
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8. 
Statistical Design and Analysis 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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8.1.1. Safety Data 
Adverse events (AE) and serious adverse events (SAE) will be captured as part of the clinical investigation  
 
 
 
 
 
 
 
8.2. 
Sample size calculation and justification 
 
Patient Participant:  
Between 40 and 45 patient participants will be recruited for this clinical investigation.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 

 
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All participants who consent and who use the investigational product 
 
 
 
 
 
  
 
9. 
Data Management 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
.  

 
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The following persons have authority to amend the CIP: 
 
 
11. 
Deviations from clinical investigation plan (CIP) 
 
 
 
 
 
 
.  
 
 
 
All deviations from the CIP shall be recorded together with an explanation for the deviation. 
 
 
 
 
 
 
 
 
 
 
 
 
r 
  

 
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The F&P 
clinical investigation is being conducted in the USA and therefore must meet 
the requirements 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
14. 
Informed Consent Process 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 

 
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15. 
Adverse Events, Adverse device effects and device deficiencies  
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

 
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16. 
Suspension or premature termination of clinical investigation 
 
  
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants will be followed up with throughout the duration of their enrolment in the clinical investigation, 
 
 
 
 
 
 
 
 
 
 
 
 
   
 

 
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