A Pilot Study - to Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly, a Pre-market Fitting
Phase: NA
Conditions: Plagiocephaly, Nonsynostotic
Sponsor: University of Texas Southwestern Medical Center

STUDY PROTOCOL  
 
Official title: A Pilot Study - to observe the effects of the Serkel cranial 
remolding orthosis on infants with deformational head shapes, a pre-
market fitting 
NCT number: NCT06831513 
IRB Approved Document date: 07-21-22 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
1 
V2Mar2018 
 
PROTOCOL FORM / RESEARCH DESCRIPTION 
 
If an item does not apply to your research project, indicate that the question is "not applicable” – do not leave sections blank 
 
Click once on the highlighted entry in each box to provide your response.  Click the item number/letter or word, if hyperlinked, 
for detailed instructions for that question.  If your response requires inserting a table, picture, etc, you may need to first delete the 
box that surrounds the answer and then insert your table or other special document. 
 
 
1.  Purpose and objectives.           List the purpose and objectives: 
 
This is a pre market fitting of a new brand of cranial remolding orthosis. Cranial remolding treatment is already an accepted 
treatment for deformational head shapes within the United States. In 2021, the FDA approved the first 3D printed cranial 
remolding orthosis. We are fitting a new to US market 3D printed cranial orthosis, which has not yet been FDA approved. The 
orthosis is nearly identical to existing FDA approved devices. It is currently being used in Australia. Would like to determine the 
functionality of this new type of helmet.   
 
 
2.  Background. 
• 
Describe past experimental and/or clinical findings leading to the formulation of your study.   
• 
For research involving investigational drugs, describe the previously conducted animal and human studies.   
• 
For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in 
relation to your protocol.   
• 
Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference.   
You may reference sponsor’s full protocol or grant application (section number and/or title) or if none, ensure background 
includes references. 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
a. 
Background 
The cranial remolding orthosis (CRO) that will be used is 3D CRO fabricated by the company Serkle. Serkle is an Australian 
company seeking to introduce their orthoses to the American market. Cranial remolding treatment is already an accepted 
treatment for deformational head shapes within the United States. In 2021, the FDA approved the first 3D printed cranial 
remolding orthosis. We are fitting a new to US market 3D printed cranial orthosis, which has not yet been FDA approved. The 
orthosis is nearly identical to existing FDA approved devices. 
 
b. 
Current practice 
Cranial remolding orthoses are used to treat deformational plagiocephaly. After receiving a plagiocephaly diagnosis from a 
physician infants from the age of 3 months to 18 months can be fitted with a cranial remolding orthosis. The orthosis is worn 
23 hours a day and while the child grows the helmet guides the growth to prevent/reduce head shape asymmetry’s. This is 
standard of care. There are also another method that is considered standard of care for more mild cases of deformational 
plagiocephaly and this is repositioning. Repositioning is when the caregiver of the parent constant repositions the infant to 
prevent him or her from lying in their flat spot. 
 
 
3.  Study Design.  
Describe the study design (e.g., single/double blind, parallel, crossover, etc.)  Consider inserting a scheme to visually present the 
study design. 
 
This is a pre-market fitting of a cranial remolding orthosis.  There will be no data collected or published through this. Serkel, the 
manufactures of the cranial remolding orthosis, may be provided information on the success of their device. Parent/caregivers 
will be provided all information regarding the new cranial remolding orthosis. Through the informed consent: 1) they will be aware 
this specific orthosis is not yet a FDA approved orthosis, 2) there are similar orthoses approved on the market 3)they will be 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
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V2Mar2018 
provided the risks of the orthosis, 4) they will be provided benefits of the orthosis. Qualified Orthotist, trained and certified in fitting 
CROs will see those participating in the pre market fitting and standards of care will be provided. 
 
 
 
4.  Research Plan / Description of the Research Methods:   
4.a.  Provide a comprehensive narrative describing the research methods.   
     1) Provide the order in which tests/procedures will be performed,  
     2) Provide the setting for these events and a description of the methods used to protect privacy during the study.   
     3) Provide the plan for data analysis (include as applicable the sample size calculation) 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
 
1) 
Infants with the diagnosis of plagiocephaly will be referred by their pediatrician for evaluation to be fit with a cranial 
remolding orthosis. Infants will be evaluated and if deformational plagiocephaly is present and treatable by CRO, 
parents/caregivers will be provided the option to be fit with a traditional CRO or the pre-market fitting CRO. Benefits and 
limitations will be provided for each. Parents/caregivers will be provide time to consider and think about both options. 
Should they decide for their child to be treated with a pre-market CRO. They will be provided and will review the 
informed consent together. Once informed consent is received, infant’s head will be scanned and CRO will be 
fabricated. 1 week later they will be fitted with CRO. And will be followed up with 1-2 week after that. After initial (1-2 
week) follow up,  will follow up every 3 weeks. (this is standard of care)   
2) 
All of the appointments (the evaluation, fitting, follow ups) will be held in the UTSW Prosthetics Orthotics clinic in a 
private patient room. Documentation will be done in Epic. Scans, pictures, and measurements sheets will be stored in a 
protected folder on Microsoft teams. 
3) 
Serkel will be providing limited amount (18) of pre-market helmets for no cost.  This determines the size of our sample, 
approximately 18 subjects, up to 25 max. 
4) 
Data collected will be cranial measurements, scans, and photos. This data will not be published, but remain in the 
patient chart. (this is standard of care procedures). Serkel manufacture is requesting initial and final cranial 
measurements/ratios (de-identified data). 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
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V2Mar2018 
 
4.b.  List of the study intervention(s) being tested or evaluated under this protocol 
 
N/A -  this study does not test or evaluate an intervention.    Skip to item 4.d. 
# 
Study intervention(s) being tested or evaluated under the protocol 
 
 
 
Add or delete rows as needed 
 
Affiliate 
 
Place a check next to 
institution(s) where the  
intervention will be 
performed 
Local Standard 
Practice?  
Indicate whether the 
intervention is 
considered 
acceptable practice 
locally for applicable 
institutions 
1 
Insert study intervention 1 here 
☐ UTSW 
☐ Yes 
☐ PHHS 
☐ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
2 
Insert study intervention 2 here 
☐ UTSW 
☐ Yes 
☐ PHHS 
☐ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
 
 
4.c.  Risk:Benefit Analysis of study interventions being tested or evaluated under this protocol 
For each study intervention identified in section 6b above, complete a risk:benefit analysis table. 
 
(Two tables are provided, copy & paste additional tables as needed or delete both tables if this study does not test an 
intervention) 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
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V2Mar2018 
4.c. 
Study Intervention #1 
Insert name used in 4.b. 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
 
 
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
5 
V2Mar2018 
4.c. 
Study Intervention #1 
Insert name used in 4.b. 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
 
 
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
6 
V2Mar2018 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
7 
V2Mar2018 
 
4.d. List ALL other research procedures or components not listed in table 4.b. 
        The combination of Tables 4b and 4d should account for all of the research procedures 
that will take place during this study. 
 
Consider grouping similar procedures under a single component (e.g., blood work, CT = safety 
assessments) 
 
 
 
# 
Research component 
• 
individual 
procedures 
 
example: 
Eligibility Assessments 
• 
History and 
physical 
• 
Questionnaire 
• 
Laboratory tests 
Add or delete rows as 
needed  
Column A 
Local Standard Practice 
Indicate the number of times 
each procedure will be 
performed as stipulated in the 
research plan that would be 
performed if the participant 
were not participating in the 
study. 
Column B 
Research Only  
Indicate the number of times 
each procedure will be 
performed solely for 
research purposes (meaning 
that the participant would not 
undergo the same number of 
procedures or would not 
undergo the procedure(s) at 
the same frequency if they 
were not participating in the 
study) 
 
Column D 
Risks 
If you are requesting a Waiver of 
Informed Consent, complete the table 
below. 
 
List the reasonably expected risks for each procedure 
or group of procedures under the following categories 
as appropriate: 
• Serious and likely; 
• Serious and less likely; 
• Serious and rare; 
• Not serious and likely; 
• Not serious and less likely 
1 
 
 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
8 
V2Mar2018 
 
This a pre-market fitting of 
a cranial remolding 
orthosis: 
• 
Physicians order 
• 
Diagnosis of 
deformational 
plagiocephaly 
• 
Infant is over 3 
months of each  
Cranial Asymmetry must be 
moderate, or fall within the 
standard guidelines to 
facilitate the necessity of a 
CRO. 
• 
Evaluation – visual, 
pictures, scans. 
(standard of care) If 
child meets 
requirements and 
CRO treatment is 
appropriate, will 
discuss purpose of 
CRO and provide 
parents/caregivers 
with details 
(benefits/limitations) 
of traditional CRO 
design vs pre-
market 3D printed 
CRO. Review 
informed consent 
together, allow 
parent/caregivers 
time to review and 
discus information 
amongst 
themselves 
• 
If they choose to 
proceed, scan and 
fabricated CRO 
(standard of care) 
• 
See back in 1 week 
for fitting (standard 
of care) 
• 
See back in 1-2 
weeks for initial 
follow up (standard 
of care) 
• 
See back every 3 
weeks for follow up 
(standard of care) 
 
This is a pre-market fitting 
of a 3D printed cranial 
remolding orthosis. No 
research will be 
performed.    
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
2 
Insert component 2 here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
3 
Insert component 3 here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
4 
Insert component 4 here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
 

Form A 
IRB # 
STU-2022-0287 
 
STU2022-0287, Spivey, FormA-ResearchProtocol, Mod_2, 07-21-22 (2) 
 
 
9 
V2Mar2018 
 
5.  Safety Precautions.  (Describe safeguards to address the serious risks listed above.) 
a.  Describe the procedures for protecting against or minimizing any potential risks for each of the more than minimal risk 
research procedures listed above. 
Those participating in pre-market fittings will be followed up with every 3 weeks and will have access (phone number and 
email) to contact treating clinician at all times. (this is standard of care) 
b.  Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse 
events, or unanticipated problems involving subjects. 
Should reaction occur that cannot be treated by Orthotist, the patient will be instructed to discontinue wearing the orthosis and 
referring physician will be contacted. If reactions are in need of immediate attention, will advise patient’s parents/caregivers to 
discontinue wearing CRO and to go to urgent care.  
c. Will the safeguards be different between/among groups?   
Yes 
 
No      This is not applicable, we not comparing  groups 
If yes, describe here