Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.
Phase: NA
Conditions: Enteral Feeding
Sponsor: Rockfield Medical Devices

Safety and Effectiveness of A Novel Enteral Feeding System: 
Prospective Study Protocol
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Safety and Effectiveness of A Novel Enteral Feeding 
System: Prospective Study Protocol
NCT06173063 

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1.0 Table of Contents: 
1.0 
Table of Contents: ................................................................................................ 2 
2.0 
Device Description ............................................................................................... 4 
2.1 
Intended Use and Indications for Use ................................................................... 8 
3.0 
Purpose ............................................................................................................... 8 
4.0 
Scope .................................................................................................................. 9 
6.0 
Appendix List ..................................................................................................... 10 
7.0 
Definitions ......................................................................................................... 11 
8.0 
Methods ............................................................................................................ 13 
8.1 
 General Methodology ....................................................................................... 13 
8.2 
Equipment ......................................................................................................... 13 
8.3 
Participants ....................................................................................................... 14 
8.4 
Inclusion and Exclusion Criteria .......................................................................... 14 
8.5 
Study Measurements ......................................................................................... 15 
8.6 
Compliance ........................................................................................................ 15 
8.7 
Selection of giving set tubing SKUs ..................................................................... 16 
8.8 
Study Schedule and Flow .................................................................................... 19 
8.9 
Screening ........................................................................................................... 22 
8.10 
Clinic Visit .......................................................................................................... 22 
8.11 
Phone Communication ....................................................................................... 23 
8.12 
 Training ............................................................................................................ 23 
8.13 
Monitoring ........................................................................................................ 23 
9.0 
Risk Benefit ....................................................................................................... 24 
10.0 
Safety Evaluation and Reporting ......................................................................... 24 
11.0 
Data Collection and Analysis .............................................................................. 24 
11.1 
Data Collection .................................................................................................. 25 
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11.2 
Data Analysis ..................................................................................................... 25 
12.0 
Data management ............................................................................................. 27 
13.0 
Maintain Records ............................................................................................... 27 
14.0 
Appendices ........................................................................................................ 28 
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2.0 
Device Description 
Device Description 
The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, 
disposable enteral feeding system intended to deliver commercially available liquid nutrition 
formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in 
the clinical or home care settings. 
The Mobility+ System delivers formula using a simple container system (“Feeding Pouch”) that has 
an internal elastomeric pump, filled by the user with formula, that gradually deflates once enabled. 
The deflation of the elastomeric pump generates a consistent, low pressure that gently pushes the 
formula from inside the elastomeric pump through the supplied tubing set (“Giving Set”) to the 
user’s extension set (or feeding tube), where the formula enters their digestive system through a 
surgically placed stoma. The progress of formula delivery is indicated by reductions in Feeding pouch 
inflation and weight, and completion of formula delivery is indicated by a cessation in formula flow 
out of the giving-set. Clinicians will consult product labelling to determine which giving-set patients 
should be guided to use, to provide for their individual flow rate needs. The system can be worn in a 
bag of choice, or in clothing, that can fit the system without kinking the tubing. 
The Mobility+ System is self-contained, portable and does not require an external pump, power 
source, or IV pole. It is designed to provide the patient greater mobility and overall ease of use. It 
operates silently, avoiding noises which can prove distracting and sleep disrupting for patients 
requiring night-time feeding. It offers the overall simplicity of operation of gravity-fed systems 
without requiring gravity to deliver formula to the patient.  
Figure 1: The Mobility+ System. Feeding Pouch (left), Filling Set and Giving Set (right); 
The Mobility+ System is single patient use, disposable and intended for use over a 24-hour period. It 
has three primary components (Figure 1). 
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Primary components 
The Feeding Pouch 
The combined pump and reservoir of the Mobility+ System (Figure 2). It consists of a flexible 
protective sleeve with an internal silicone elastomeric pump. 
To fill the Feeding Pouch, the Filling Set is attached to the spout. As the Feeding Pouch is filled with 
formula, it inflates. This inflation generates the mechanical force used to dispense the formula in a 
controlled manner, without any external energy source or need for gravity. Once filled, the Filling set 
is detached from the spout. The Feeding Pouch can hold a maximum of 500 ml of formula and a 
minimum of 250 ml.  
Figure 2: Feeding Pouch (left), Internal Schematics (right, empty & full) 
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The Filling Set 
Tubing that transfers commercially available nutritional formula from its packaging to the Feeding 
Pouch using ENFit® connectors and a syringe (Figure 3). 
Figure 3: The Filling Set and Syringe 
Note: A 60 ml ENFit® syringe (Figure 3) is not included with the Mobility+ System. It is 
an ancillary device used in the transfer of formula from the formula packaging (‘feed container’ in 
Figure 3) to the Feeding Pouch, with the use of the Filling Set. 
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The Giving Set 
Tubing that connects the Feeding Pouch to the ENFit® connector of the user’s extension set (or 
feeding tube), (Figure 4). The Giving Set is available in a variety of lengths to give a range 
of formula flow rates (Figure 5).  
Once the Feeding pouch is filled using the Filling set (figure 3), the Giving Set is attached to the 
Feeding Pouch with the clamp of the Giving Set tubing closed. Formula flow is enabled by opening 
the clamp. The system is then primed (allowing the Feeding Pouch to fill the Giving Set tubing with 
formula to clear air, if any, from the elastomeric pump and the Giving Set tubing itself). The formula 
flow is disabled by closing the clamp. The Giving Set is attached to the extension set (or feeding 
tube). The Mobility+ System is now ready. Once again, formula flow is enabled by opening the clamp. 
Figure 4: The Giving Set 
Figure 5: Available Giving Set lengths 
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The Mobility+ System may be worn in a bag of choice that can fit the filled Feeding Pouch without 
kinking the Giving Set tubing. The Instructions for Use guides the user to place the spout of the 
Feeding Pouch within 15cm (6 inches) above or below the user’s stoma when feeding. 
All connectors in the Mobility+ System comply with the FDA-recognized ENFit® standard (ISO 80369-3 
and ISO 18250-3). 
2.1 
Intended Use and Indications for Use 
Intended Use 
The Rockfield Medical Devices Mobility+ Enteral Feeding System is intended to deliver liquid nutrition 
formula to an enteral access device (feeding tube) in users aged 2 years and over. 
Indications for Use 
The Rockfield Medical Devices Mobility+ Enteral Feeding System is intended to deliver liquid nutrition 
formula to an enteral access device (feeding tube) in users aged 2 years and over. 
3.0 
Purpose 
The purpose is to evaluate the safety and effectiveness of Mobility+ enteral feeding system via this 
initial post-market study (510k clearance number K222678) in adults, a subset of the intended use 
population. This evaluation will be conducted in a prospective, single arm, non-randomized clinical 
study.  
Hypothesis and Objectives 
The study hypothesis is that Mobility+ meets its intended use, safely. The objectives are to evaluate 
the below primary and secondary endpoints, through execution of this protocol: 
Endpoint 
Detail 
How it will be 
measured 
Primary: Safety 
and Effectiveness 
of Mobility+ 
Evaluate 
participants 
who 
have 
received 
familiarization training can use device, according to 
IFU, to allow delivery of liquid nutrition to their 
feeding tube, in a real-life setting (home), 
safely (i.e. can execute critical device use tasks to 
allow feeding, without serious adverse events)  
and  
with effectiveness (i.e. using Mobility+ for the 
majority or all of their feeding sessions i.e. two daily 
feeds, minimum)  
Phone communication 
and checklist 
 (Appendix8) 
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Secondary: 
Usability of 
Mobility+ 
Evaluate Participant perspectives on mobility, ease 
of use and tolerance, with their current feeding 
system(s) and Mobility+ 
Participant 
perspectives surveys: 
Baseline (Appendix 4) 
End of study (Appendix 
7) 
Evaluate changes in participant Quality of Life 
(QoL) 
QoL survey at baseline 
(Appendix 5) and QoL 
question at end of 
study (Appendix 7) 
Estimate if participants consume similar average 
volume (and kcals) of feed/day during the study, 
compared to baseline 
Collect descriptive data 
on estimated average 
feed volume and kcals 
consumed at baseline 
(Appendix 3) and at end 
of study (Appendix 8) 
The outcome will be presented in a study report. 
4.0 
Scope 
The scope is a post-market clinical study with adult users, in line with the scope of identified users as 
per the Usability Engineering File (DR010), with the Mobility+ system, which includes the 4 REF codes 
below.  
REF code 
Product 
Mob1- 440 
Mobility+ with 440mm Giving Set 
Mob1-700 
Mobility+ with 700mm Giving Set 
Mob1-1000 
Mobility+ with 1000mm Giving Set 
Mob1-1900 
Mobility+ with 1900mm Giving Set 
The scope includes use of the Mobility+ via filling the system from feed poured into a container (See 
IFU Filling Method A) and excludes filling the system from a ready to hang feed bag (Filling Method B, 
IFU). 
ISO 14155 principles are applied in part to this protocol, to suit the clinical developmental stage of 
Mobility+ and study design, in line with Annex I I.7 ISO 14155:2020. 
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6.0 
Appendix List 
Appendix 1: Screening Log 
Appendix 2: Screening questionnaire  
Appendix 3: Demographics questionnaire 
Appendix 4: Participant perspectives baseline survey 
Appendix 5: QoL survey  
Appendix 6: Phone communication check sheet – Trial days 
Appendix 7: Participant perspectives outcome survey 
Appendix 8: Phone communication check sheet (Study Day 7 and 14) 
Appendix 9: Adverse event classifications 
Appendix 10:  Adverse events logging method 
Appendix 11: Participant familiarization training 
Appendix 12: Participant familiarization training record 
Appendix 13: Operator training record 
Appendix 14: Evidence of expert review  
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7.0 
Definitions 
Term 
Description 
User 
Person interaction with medical device 
Operator 
Operators are study staff who have self-trained in the use of 
Mobility+ and who have received training in the execution of this 
Protocol by the sponsor, Rockfield Medical Devices. Study staff in 
this study comprise advanced nursing practitioners, registered 
dietitians, researchers and principal investigator. 
Participant 
Individual who is or becomes a participant in a clinical investigation, 
as a recipient of the investigational device. Note that ‘participants’ in 
this study are users of the device who are being enterally fed in 
clinical settings or who are feeding at home (as per Usability 
Engineering File DR010). 
Investigational 
medical device 
Medical device being assessed for clinical performance, 
effectiveness, or safety in a clinical investigation 
Clinical 
effectiveness 
Achievement of a clinically significant intended result in a defined 
portion of the target population when the investigational medical 
device is used within its intended uses and according to its 
instructions for use, as determined by documented scientific 
evidence 
Malfunction 
Failure of an investigational medical device to perform in accordance 
with its intended purpose when used in accordance with the 
instructions for use  
Principal 
Investigator 
Qualified person responsible for conducting the clinical investigation 
at an investigation site 
Use error  
(ISO 14155:2020) 
User action or lack of action while using the medical device that 
leads to a different result than that intended by the manufacturer or 
expected by the user. 
Note:  Use error includes inability of the user to complete a task.  
Adverse event (AE) 
(ISO 14155:2020) 
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 and whether anticipated or 
unanticipated 
Serious adverse 
 adverse event that led to any of the following 
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effect (SAE) 
a)
Death
b)
Serious deterioration in the health of the subject, users, or
other persons as defined by one or more of the following:
1)
A life-threatening illness or injury, or
2)
A permanent impairment of a body structure or a body function
including chronic diseases, or
3)
In-patient or prolonged hospitalization, or
4)
Medical or surgical intervention to prevent life-threatening illness
or injury, or permanent impairment to a body structure or a body
function,
c)
Fetal distress, fetal death, a congenital abnormality, or birth
defect including physical or mental impairment
Adverse device 
effect (ADE) 
Adverse event related to the use of an investigational medical 
device. 
Serious adverse 
device effect (SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event 
Unanticipated 
serious adverse 
device effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, severity 
or outcome has not been identified in the current risk assessment 
Note: Anticipated serious adverse device effect (ASADE) is an effect which 
by its nature, incidence, severity or outcome has been identified in the risk 
assessment 
Serious public 
health threat 
Serious public health threat, means an event which could result in 
imminent risk of death, serious deterioration in a person's state of 
health, or serious illness, that may require prompt remedial action, 
and that may cause significant morbidity or mortality in humans, or 
that is unusual or unexpected for the given place and time 
Stock-Keeping Unit 
(SKU) 
A Stock-Keeping Unit is a number (and sometimes letters) that is 
assigned to a product for the purpose of inventory management and 
ease or tracking 
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8.0 
Methods 
8.1 
General Methodology 
The study duration will allow 25 participants to use the Mobility+ system for their feeding sessions 
over the course of 14 consecutive days, following an initial 7-day period where participants have time 
to trial and get used to the new system. As determined by the PI, five to seven pre-intervention days 
(During ‘Trial days’ 1 to 7), with a minimum of 5, is time to allow participants to become familiar with 
a new feeding system (i.e., Mobility+) and 14 days (Study Day 1 through Day 14 inclusive) is the time 
required to effectively assess safety and effectiveness of Mobility+(as outlined in Appendix 8). 
The environment is Mayo Clinic Setting at study outset for the clinic visits where participants will be 
screened, consented, and enrolled. Participants’ homes are the setting for the 21-day study duration. 
Mobility+ Devices will be built by a process detailed within  a Mobility+ Work Instruction, from within a 
quality management system. The work instruction will be in place at the time of Mobility+ production runs 
occurring before execution of this protocol.  
  8.2  
Equipment 
Component description 
Name 
Mobility+ device 
Mobility+ Enteral Feeding System 
ENFit Syringe. 
 Reusable, 60ml ENFit syringe 
Generic cross body bags to wear 
Mobility+ in 
Off the shelf brand 
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8.3 
Participants 
This is a first in human post-market clinical study to evaluate the Mobility+ system, being carried out 
following market approval (i.e., FDA clearance). 25 participants will be enrolled to ensure data can be 
obtained for 20 participants (the expected drop-out rate is estimated at ~20%), as this is considered 
appropriate for a post-market clinical study on a low-risk device and will add meaningful data to device 
risk management files. If more than 5 participants drop out, re-recruitment will aim to bring the 
sample size up to 20. 
Recruitment will aim to obtain a mix of female and male participants who meet the inclusion criteria. 
Screening questions will be used by operators during the recruitment process to ensure participants 
are eligible (See Appendix 1 and Appendix 2).  
8.4 
Inclusion and Exclusion Criteria 
Inclusion 
criteria 
1.
Participants with Gastrostomy (G) tube or Jejunostomy (J) tubes
2.
Participant must require enteral tube feeding every day, as determined at the
time of study enrolment
3.
Participant must use commercially available enteral formula with standard
enteral feeding system(s) (gravity bag, bolus, pump or combination(s)), for some
or all of their tube feeds, for daytime or day and night-time feeding
4.
Participant must be EN dependent i.e., 500 ml minimum daily feed intake from EN
5.
Participants must be able to swap from current system to Mobility+ for a
minimum of two daily feeds per day for duration of study (Study days 1 -14)
6.
Participant must be >= 18  to reflect the subset of the intended use population
being evaluated
7.
Participant must be willing to participate in the study and provide consent).
8.
Participants must have been on an enteral feeding regime for a minimum of 10
weeks
9.
Participants clinical functional capacity is adequate as determined by operator
clinical judgement, to enable them to participate fully in the study
10. Participants are suitable candidates for using Mobility+ as determined by operator
clinical judgement on participant enteral feeding needs (as per prescription) and
alignment with Mobility+ Flow Rate Guide (see Giving Set SKU decision tree for
prescribing Mobility+ Figure 6)
Exclusion 
Criteria 
1.
Participants who do not use commercially available enteral formula for some or
all their formula needs
2.
Participants unable/unwilling to provide consent
3.
Participants whose enteral feeding needs do not match the offering of the
Mobility+, as determined by operator clinical judgement (see Decision Tree for
prescribing Mobility+ Figure 6)
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4.
Participants who have inadequate clinical functional capacity, as determined by
operator clinical judgement to participate fully in the study e.g. neuromuscular or
neurodegenerative disorders, or developmental delay.
5.
Participants with very limited mobility, as determined by operator clinical opinion
Note: In considering functional capacity, the operator will consider the ability to conduct critical tasks 
associated with successful use of Mobility+ (i.e.  removal of protective caps; connecting filling set to 
pouch in correct orientation; operating clamps; orientating 3-way valve; pushing syringes of feed into 
pouch; disconnecting tubing (filling and giving sets); connecting giving set to extension set or feeding 
tube; wearing Mobility+ and coiled tubing on the body; Sit, walk, and stand while wearing Mobility+) 
8.5   
Study Measurements 
The study measurements which will be taken are detailed in Table 3 below: 
Table 3: Study measurements 
Baseline measurements: 
•
Demographics (Appendix 3)
•
Average volume and Kcals of feed consumed / day
(Appendix 3)
•
Quality of life measure (Appendix 5)
•
Participant perspectives on mobility, ease of use (current
system(s)) and feeding intolerance symptoms (Appendix 4)
Trial days 
•
Tubing SKU check (Appendix 6)
Interim 
survey 
questions 
(Study Day 7) 
•
Tubing SKU check, safety and effectiveness check,
compliance and calorie intake check (Appendix 8)
End of study measurements 
(Study Day 14): 
•
Quality of life question (Appendix 7)
•
Participant perspectives on mobility and ease of use of
Mobility+ system (Appendix 7)
•
Note of tubing SKU used, safety and effectiveness check,
compliance and calorie intake check, General end of study
questions (wearing, wellbeing, future use etc.) (Appendix 7)
8.6 
Compliance 
Phone communication surveys on Study days 7 and 14 will collect information on the amount 
participants are using, to capture if they are using Mobility+ for a minimum of 2 daily feeds 
(Appendix 8). 
Note: In some cases, participants may not comply fully with their enteral feeding regime due to 
issues unrelated to the study or feeding system. At screening, potential participants will be asked 
how often they skip or cut-short feeding sessions to determine if general compliance with enteral 
nutrition (EN) feeding may be an issue.  Questions on compliance will also be asked on Study Days 7 
and Day 14 (See Appendix 8). Poor compliance (participants who take less than two daily feeds using 
Mobility+), should it occur, will be reported in the study results and sub analyses will be conducted 
on participants who met the criteria. 
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8.7 
Selection of giving set tubing SKUs 
During eligibility screening, patient e-medical records will be reviewed to allow operators to 
determine if the Mobility+ system is suitable for potential participants based on the enteral nutrition 
formula the person uses, their estimated flow rate needs (mls/hour), and the information in the 
Mobility+ Flow Rate Guide (FRG) on indicative flow rates achieved with various formula and tubing 
SKU combinations. Note: The process of healthcare professionals using the FRG to allow selection of 
an appropriate tubing SKU is validated by expert review .  
Operators will use FRG and the potential participant’s enteral feeding regimen prescription to 
estimate which giving –set tubing SKU (from four available options) best suits the participant’s 
needs, with the approach being to pick the SKU which will provide a flow rate that is slightly slower 
than the participant's estimated flow rate. The operator will refer to the Decision Tree for 
Prescribing Mobility+ (see Figure 6) when deciding if the potential participant should be invited for a 
clinic visit.  
Figure 6: Decision Tree for prescribing Mobility+ 
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During the clinic visit, the operator will administer the screening questionnaire (Appendix 2) which 
will allow the operator to gauge the participant’s calculated average flow rate. The operator will 
then use the participant’s calculated average flow rate, the FRG and Decision Tree for Prescribing 
Mobility+ (see Figure 6) to make a final decision on which giving set SKU the participant will begin 
the trial period with. As per the Decision Tree for Prescribing Mobility+, the operator will prescribe 
the giving set SKU which provides a flow rate slower than the participant’s calculated average flow 
rate and exercise caution when prescribing the 1900mm for use in the trial. This reduces the 
likelihood of the participant starting the trial with flow rates that are too high, and reduces the risks 
associated with this e.g. nausea and vomiting, among others. The trial period will allow time for an 
assessment on whether this initially selected tubing SKU is the best-fit for the participant to continue 
to use for the study days.  
Participants will be made aware at enrollment that operators who are licensed to prescribe enteral 
feeding systems may advise changes to the giving-set tubing SKU they use, throughout the study, 
should clinical and participant factors necessitate this. 
During phone communications in the trial period days, the operator will advise the participant 
about what, if any, changes to make to the tubing SKU they are using, which will be logged 
(Appendix 6).  If necessary, participants will be advised by the operator to move to tubing SKUs 
which provide faster or slower flow rates as tolerated (See Phone Communication Decision Tree 
Figure 7), until the participant has their optimum tubing SKU selected by the end of the trial period, 
for use during the study days. The participant will then ideally continue with the selected tubing SKU 
for the duration of the study days.  
Figure 7: Phone Communication Decision Tree 
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However, on study Day 7 operators will discuss the tubing SKU being used with the participant and 
advise if any changes need to be made. Any changes made to the SKU being used will be logged by 
the operator (Appendix 6). On study day 14 (at outcome), operators will log the SKU that 
participants finished the trial with.  
Participants will be supplied with devices, tubing SKUs and other consumables necessary, for trial 
period and study days. 
Table 4 and Figure 8 below summarizes the study schedule and the subsequent text details what 
occurs at screening and baseline visit, and in the pre-intervention and intervention phases.  
Note: Operators will, if applicable, log reports on 1) surveys/phone communications that subjects fail 
to respond to (including reasons), and 2) participants withdrawn (including reason for withdrawal) 
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8.8 
Study Schedule and Flow 
Table 4. Study Schedule 
Pre 
intervention 
Intervention Phase (21 consecutive days) 
Day 
 Clinic Visit 
Trial 
Days 
1 to 7 
Study 
Day 1 
Study 
Day 2 
Study 
Day 3 
Study 
Day 4 
Study 
Day 5 
Study 
Day 6 
Study 
Day 7 
Study 
Day 8 
Study 
Day 9 
Study 
Day 
10 
Study 
Day 
11 
Study 
Day 
12 
Study 
Day 
13 
Outcome 
Study 
Day 
14 
Clinic visit 
X 
Phone 
Communication 
X 
(days 
1,3,5 ) 
X 
X 
Participant info 
sheet 
X 
Screening 
Questionnaire 
X 
Giving Set Tubing 
Selection 
X 
Consent & data 
privacy, Enrolment 
X 
Record 
Demographics 
X 
Familiarization 
Training 
X 
Device First clinical 
use  
X 
Participant 
perspectives survey 
X 
X 
- QoLmeasure
X 
X 
Estimate EN intake 
(kcals & volume) 
X 
X 
X 
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Pre 
intervention 
Intervention Phase (21 consecutive days) 
Day 
 Clinic Visit 
Trial 
Days 
1 to 7 
Study 
Day 1 
Study 
Day 2 
Study 
Day 3 
Study 
Day 4 
Study 
Day 5 
Study 
Day 6 
Study 
Day 7 
Study 
Day 8 
Study 
Day 9 
Study 
Day 
10 
Study 
Day 
11 
Study 
Day 
12 
Study 
Day 
13 
Outcome 
Study 
Day 
14 
Clinic visit 
X 
Phone 
Communication 
X 
(days 
1,3,5 ) 
X 
X 
General End of 
Study Questions 
X 
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Figure 8. Study Flow Chart 
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8.9 
Screening 
•
Conduct eligibility screening using the eligibility screening log (see Appendix 1) and
information from patients’ electronic medical records. Ensure that the candidate meets the
study inclusion criteria. Check if the candidate’s enteral nutrition formula is listed on the
Mobility+ FRG.
▪
Develop an understanding of the candidate’s flow rate needs. Information on flow rates may
be listed in patient electronic medical records or determined based on information such as
patient diagnosis, feeding method and type of feeding tube. Where necessary, consult with
other study staff (e.g dietitian) to determine a patient’s estimated flow rate range and
maximum flow rate likely to be tolerated.
▪
Consult FRG and use the Giving Set SKU decision tree for prescribing Mobility+ (see Figure 6)
to estimate a suitable giving set SKU for candidates. Note, if the indicative flow rates in the
FRG are not suitable for the candidate, they are not eligible for inclusion in the study.
▪
Assess whether a candidate’s mobility and clinical functional capacity are adequate to allow
them to participate in the trial.
▪
Contact eligible candidates by phone and give them a brief description of the clinical trial.
Schedule a clinic visit with candidates that are interested in participating in the trial.
8.10 
Clinic Visit 
The following activities are carried out during the clinic visit.: 
▪
Provide the information sheet to the participant. Obtain informed consent verbally and via
e-signature, and agreement with data privacy policy[SW1].
▪
Officially enroll participant.
▪
Administer the screening questionnaire (Appendix 2) to confirm participant eligibility
▪
Revisit the FRG and Decision Tree for Prescribing Mobility+, and use the additional information
generated through the screening questionnaire to make a final decision on the appropriate
giving-set tubing SKU (Appendix 2) for participants to begin the trial period with.
▪
Advise participant that operators (licensed to prescribe) may change the giving-set tubing
SKU participants are to use, during the trial and or study days, if clinical and participant
factors indicate this is needed (e.g. participant reflux may necessitate a change to slower
flow rate, or participant finding feeding times too long may necessitate a change to a faster
flow rate)
▪
Answer any queries
▪
Record the demographic data including calorie intake (Appendix 3).
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▪
Administer the participant perspectives baseline survey (Appendix 4) and quality of life
survey (Appendix 5).
▪
Provide familiarization training as per Appendix 11.
▪
Provide necessary consumables.
8.11 
Phone Communication 
1.
Pre-intervention phase – Trial days
Phone communication on Trial Days 1; 3 and 5: Participant is contacted by telephone to ensure 
the participant is becoming familiar with using the device including the most appropriate giving-
set tubing SKU. (Appendix 6). 
2.
Intervention phase – Study days
➢
Phone communication - Study Day 7: Participant is contacted by telephone to ensure they are
successfully and safely feeding with an appropriate tubing SKU, and check compliance and
calorie intake (Appendix 8).
➢
Phone communication -Study Day 14: Participant is contacted by telephone to ensure
participant is successfully and safely feeding with an appropriate tubing SKU, and check
compliance and calorie intake. Operator also evaluates self-perceived wellbeing, mobility,
wearing methods, and longer-term device use wishes (Appendix 8) Administer participant
perspectives outcome survey, including question on QoL (Appendix 7)
Note: Regarding disposal – as per IFU, devices are disposed of alongside normal waste. 
8.12 
 Training 
Participants will be familiarized with how to use Mobility+ by the trained operator (Appendix 11).  
Operators will log completion of familiarization training (Appendix 12). The operator advises the 
participant that the first 7 days of the use during the study are effectively a trial period to enhance 
comfort and familiarity with the system, before the 14-day intervention phase (Study Day 1 through 
Study Day 14) of the study.  
Operators are to self-train in the use of Mobility+ (as detailed in DR010) and be trained in the 
execution of this Protocol by the sponsor, Rockfield Medical Devices (Appendix 14), before study 
execution. The sponsor will be available to provide continuous training to the operators throughout 
the duration of the study, as necessary. 
Participants will be provided with the contact phone number of the Operator in case of questions or 
concerns. 
8.13 
     Monitoring 
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PI will monitor participants experience of feeding with Mobility+ during the study as per schedule of 
phone communications in Table 4 Study Schedule, and as outlined in Appendices 6 and 9 Should any 
adverse events or health threats become known to the operator via phone communications or 
otherwise, the operator will proceed to assess these as per Appendices 9 and 10. Furthermore, 
participant hospitalization for any reason during the trial days or study days will necessitate the 
ceasing of a participant's participation in this study (Appendices 6 and 8). 
9.0 
Risk Benefit 
Risks associated with the investigational device and its use have been estimated in accordance with 
ISO 14971 prior to the development of this protocol. As part of ongoing risk management processes 
throughout the lifecycle of the device, and in line with SOP004, FMEA (Failure modes effects 
analysis) has been used to evaluate risks that may occur through use of the device and controls have 
been implemented to reduce risk to acceptable levels. Residual risks are deemed reduced as far as 
possible and are communicated in device labelling and other mitigation activities as per sponsor Risk 
documents. Benefits associated with the device outweigh risks.  Risk benefit will be updated in risk 
management files (FMEA and Mobility+ Risk Management Report) following completion of the study 
report. 
10.0  
Safety Evaluation and Reporting 
Safety evaluation and reporting will take place in line with Rockfield Medical Devices Quality 
Management System and SOPs on feedback and complaint management (SOP022 Customer 
Complaint Process Management). 
The Principal Investigator (PI) undertakes to follow their institutes Institutional Review Board (IRB) 
policies regarding safety evaluation and reporting, and record AE’s, SAE’s, device deficiencies 
(including those which could lead to SADEs) and serious health threats, conduct an assessment on 
these, and report them to the IRB within 24 hours if the matter is considered serious, detailing the 
determination and action taken. 
The PI also undertakes to report serious matters in a timely manner (within 24 hours) to the sponsor 
as per Appendix 10, following which the sponsor will review if the PIs assessment, determination, 
and actions are appropriate. The sponsor will also follow the sponsors relevant procedure on 
reporting (SOP022) and data outputs will be reviewed as part of SOP024.  
11.0 
Data Collection and Analysis 
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11.1 
Data Collection 
Data from screening, surveys and phone communications will be collected by operators and input 
directly into the Mayo Clinic Electronic Data Capture (Redcap) system. 
11.2  
Data Analysis 
Table 5 below details how data from the surveys will be analyzed. 
Table 5: Details of how measurements will be analyzed 
Measurement 
General details on purpose 
of analysis 
Specific details on analysis 
Participant 
perspective 
surveys 
Feeding 
system 
surveys 
at 
baseline and end of study, to 
assess participant perspectives 
on feeding system specific 
parameters and the impact of 
converting from usual system(s) 
to Mobility+ 
 Surveys consist of 16 five-
point Likert scale type 
questions, where rating 
options either range from very 
difficult to very easy, or 
strongly disagree to strongly 
agree. The ratings are assigned 
a point scoring system, 
whereby the most negative 
option (i.e. very difficult or 
strongly disagree) is assigned 0 
points and the most positive 
option (i.e. very easy or 
strongly agree) is assigned 4, 
meaning the total possible 
maximum score is 64 points. 
As participants are asked to 
complete these surveys at 
baseline and at study end, the 
overall score obtained with 
their usual systems can be 
compared to the overall score 
obtained after using Mobility+. 
Scores for individual questions 
can also be compared. 
QoL measures 
(Qol survey at baseline and QoL 
question at end of study) 
A simple QoL measure will be used
at 
baseline 
 
to 
gauge 
participants overall QoL using a 
scale previously published (See 
Appendix 5) accompanied by a 
simple question evaluating if 
self-perceived 
QoL 
has 
changed, at end of study  
Determine baseline QoL 
Evaluate any changes to QoL in 
the second week of study 
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General 
End 
of 
Study 
Questions 
This survey is designed to 
assess changes in participants 
perceived 
wellbeing 
and 
mobility from study start – 
where they used their usual 
feeding system – to study end 
with Mobility+. It will also 
capture additional information 
on Mobility+ usage patterns 
and consumer demand for 
Mobility+. 
The survey consists of 9 simple 
questions which 
predominantly assess change 
in participants perceived 
wellbeing and mobility with 
Mobility+ versus their usual 
systems.  The questions are 
mostly Likert scale type 
questions where answer 
options range from “much 
better” to “much worse”.  
Additional questions assess 
the importance of mobility to 
the participant, how the 
participant wore the Mobility+ 
and if the participant would 
like to use the Mobility+ again, 
among others. Data collected 
will supplement Qol and 
participant perspectives data. 
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12.0  
Data management 
A validated Electronic Data Capture system will be used at the study site, which complies with all 
relevant local and national rules.
13.0 
Maintain Records 
Records shall be maintained in accordance with SOP002 Control of Records Procedure. 
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14.0 
Appendices 
Appendix 1 
Eligibility-Screening Log 
Date: 
Operator(s) ID: 
Questions: 
Answers: 
All answers to the following questions must be ‘YES’ for a candidate to be deemed eligible for this 
Study. 
1.
Is the candidate at least 18 years of age?
YES 
☐ 
NO 
☐ 
2.
Do they have a gastrostomy tube or jejunostomy tube?
YES 
☐ 
NO 
☐ 
3.
Do they use a standard enteral feeding system (gravity bag, enteral
nutrition pump, bolus or combination(s)?
YES 
☐ 
NO 
☐ 
4.
Have they been on an enteral feeding regime for greater than or
equal to 10 weeks?
YES 
☐ 
NO 
☐ 
5.
Do they currently require greater than or equal to 500ml enteral
nutrition every day?
YES 
☐ 
NO 
☐ 
6.
Do they tube feed either during the day or day and night?
YES 
☐ 
NO 
☐ 
7.
Is their clinical functional capacity adequate to enable them to
participate fully in the study? (Determined by operator clinical
judgement)
YES 
☐ 
NO 
☐ 
8.
Is the patient mobile? (Determined by operator clinical opinion)
YES 
☐ 
NO 
☐ 
9.
Do they currently use a commercially available enteral formula that is
listed on the Mobility+ Flow Rate Guide?
YES 
☐ 
NO 
☐
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Appendix 2 
Screening Questionnaire 
(Operator asks the Participant these questions) 
Participant ID: 
Date: 
Operator(s) ID: 
Questions: 
Answers: 
1.
What type of feeding system(s) do you use?
GRAVITY BAG 
☐ 
PUMP 
☐ 
SYRINGE/BOLUS 
☐ 
COMBINATION 
☐ 
If COMBINATION, please give detail ………………………………………………………. 
2.
What is the name of the enteral feed you 
use?
 Brand: 
  …………………… 
Type: 
 ……………………………. 
3.
Do you feed during the day, at night or a combination of both?
DAY 
☐ 
NIGHT 
☐ 
COMBINATION 
☐ 
4.
What volume (and kcals) of enteral nutrition do you
typically consume over a 24 hour period?
  ………. mls 
    ..….…… kcals 
5.
How many feeding sessions do you have per day?
 …………………….. 
6.
How many hours do you typically infuse for over a 24 hour 
period?
 ……… hours 
 ………. minutes 
7.
What flow rate do you typically use (i.e. per feeding, what ml of formula do you provide over how
many minutes)?
0-50ml/hr
☐
50-100ml/hr
☐
100-150ml/hr
☐
150-200ml/hr
☐
>200ml/hr
☐
 UNSURE* 
 ☐ 
*Calculated Average Flow Rate:
 …………………………………………. 
8.
How many full feeding sessions do you miss a day?
   0    1    2    3    4    Other 
9.
How many feeding sessions do you cut short each day?
  0    1    2    3    4    Other 
10. Are you able to swap from your current system to Mobility+ for a
minimum of two daily feeds (operator calculates this volume using
YES 
☐ 
NO 
☐
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answer to Q.4 and Q.5) for a trial period of 5 -7 days, followed by 
14 consecutive study days?  
*Note to operator: minimum device fill is 250ml (as per precautions in IFU)
Operator Facing Questions 
11. Is the subject a suitable candidate for using Mobility+ based on their
enteral feeding needs and alignment to the Mobility+ Flow Rate Guide
(See giving set SKU decision tree for prescribing Mobility+ Figure 6)
YES 
☐ 
NO 
☐ 
The candidates feed and flow rate needs mean the most appropriate tubing SKU to start them on during 
trial days is:  
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐
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Appendix 3 
Demographics questionnaire 
(Operator asks the Participant these questions where these elements are not already captured from Electronic 
Medical Records) 
Questions: 
Answers: 
Are you male/female? 
   Male 
   ☐ 
  Female 
   ☐ 
What is your age? 
  ………………   (years) 
What is your height (cm)? 
 ……………… cm 
What is your weight (kg)? 
 ……………… kg 
What is your diagnosis? 
Note: Operator selects a standard 
pathophysiological mechanism from list 
☐Malignancy
☐Mechanical Obstruction
☐GI Dysmotility
☐Hepato-biliary/Pancreatic
☐Mucosal Disease
☐Trauma/Injury
☐Neuro-degenerative Disease
☐Short Bowel Syndrome
☐Functional Disorder
☐Bariatric Surgery
☐Congenital/Developmental
Are you working or studying (or both)? 
Yes, I work, study or both 
☐ 
No, I neither 
work or study 
☐ 
Which type of feeding tube do you have? 
G-tube
☐
J-tube
☐
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Appendix 4 
Participant perspectives baseline survey 
Participant perspectives of current feeding system: Usability, mobility and ease of use 
 (Operator asks the Participant these questions) 
During use of your current 
feeding system, how do you 
find these activities? 
Very Difficult  
Difficult 
Neutral 
Easy 
Very Easy 
Moving from one room to 
another room  
Going up and down stairs 
Short walk (e.g., one block) 
Long walk (e.g., several 
blocks)  
Travelling in car/public 
transport 
Moderate intensity physical 
activities, such as: 
-
Moving a table
-
Pushing a vacuum
-
Bowling
-
Playing golf
Other daily activities (e.g., 
lifting or carrying groceries, 
household chores)  
Ability to sleep 
Socializing with friends/family 
During use 
of your 
current 
feeding 
system, 
how do you 
find 
working/ 
studying or 
both? 
Please log 
as N/A if 
participant 
does 
neither. 
Very 
Difficult 
Difficult 
Neutral 
Easy 
Very Easy 
N/A 
Note to operator: When scoring this questionnaire, assign points using the legend below. 
Very Difficult = 0 points, Somewhat Difficult = 1, Neutral = 2, Somewhat Easy = 3 and Very Easy = 4 
Thinking about your overall 
experience with your current 
system, how strongly do you 
Strongly 
Disagree 
Some-
what 
Disagree 
Neutral 
Some-
what 
Agree 
Strongly 
Agree 
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agree or disagree with the 
following statements? 
My current system is easy to 
use  
My current system is easy to 
carry  
The noise level of my current 
system during use (including 
alarms) is acceptable 
My current system allows me 
to feed discreetly 
I am satisfied with the overall 
performance of my current 
system  
Note to operator: When scoring this questionnaire, assign points using the legend below. 
Strongly Disagree = 0 points, Somewhat Disagree = 1, Neutral = 2, Somewhat Agree = 3 and Strongly 
Agree = 4 
Do you experience any of the 
following symptoms of feed 
intolerance while using your 
current feeding system? 
Gas/Bloating? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Abdominal Pain? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Diarrhea? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Constipation? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Nausea/Vomiting? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Mild   
☐ 
Mild   
☐ 
Reflux? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Mild   
☐ 
Mild   
☐
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Appendix 5 
QoL survey 
(Operator asks the Participant these questions) 
Reference: Elfadil OM, Patel A, Abdelmagid M, et al. 1117929 - Mental Health Among Enteral Feeding 
Patients and Caregivers: Is Home Enteral Nutrition Overwhelming? Nutrition and Metabolism 
Research Oral Paper Session Abstracts. ASPEN Nutrition Science & Practice Conference: March 26-29, 
2022 
(Seattle, 
WA). 
JPEN 
J 
Parenter 
Enteral 
Nutr. 
2022 
Mar;46 
(S1) 
https://aspenjournals.onlinelibrary.wiley.com/doi/full/10.1002/jpen.2344 
Rate your quality of life 
Excellent 
Good 
Neutral 
Bad 
Very Bad 
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Appendix 6 
Phone Communication check sheet – Trial days 
(Operator to use this check sheet to log tubing SKU and changes) 
Tubing SKU check 
Trial Day 1:  
SKU that participant is using: 
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐ 
Select one: 
Stay on this SKU 
☐ 
Trial ___________ SKU 
☐ 
Reason for changing: 
Trial Day 3: 
SKU that participant is using: 
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐ 
Select one: 
Stay on this SKU 
☐ 
Trial ___________ SKU 
☐ 
Reason for changing: 
Trial Day 5: 
SKU that participant is using: 
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐ 
Select one: 
Stay on this SKU 
☐ 
Trial ___________ SKU 
☐ 
Reason for changing: 
Have you been admitted to 
hospital in the last 5 
days/during this trial period? 
☐Yes
☐No
Note to operator: Confirm you 
have reminded participant of 
the day they will begin the 14 
day study period 
☐Yes
☐No
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Appendix 7 
Participant perspectives outcome survey  
Participant perspectives of Mobility+ feeding system: Usability, mobility, and ease of use, including 
general end of study questions 
 (Operator asks the Participant these questions) 
During use of the Mobility+ 
system, how do you find these 
activities? 
Very Difficult 
Difficult 
Neutral 
Easy 
Very Easy 
Moving from one room to 
another room  
Going up and down stairs 
Short walk (e.g., one block) 
Long walk (e.g., several blocks) 
Travelling in car/public transport 
Moderate intensity physical 
activities, such as: 
-
Moving a table
-
Pushing a vacuum
-
Bowling
-
Playing golf
Other daily activities (e.g., lifting 
or carrying groceries, household 
chores)  
Ability to sleep 
Socializing with friends/family 
During use 
of the 
Mobility+ 
system, 
how did you 
find 
working/ 
studying or 
both? 
Please log 
N/A if 
participant 
does 
neither 
Very 
Difficult 
Difficult 
Neutral 
Easy 
Very Easy 
N/A 
Note to operator: When scoring this questionnaire, assign points using the legend below. 
Very Difficult = 0 points, Somewhat Difficult = 1, Neutral = 2, Somewhat Easy = 3 and Very Easy = 4 
Thinking about your overall 
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experience with the Mobility+ 
system, how strongly do you 
agree or disagree with the 
following statements? 
Strongly 
Disagree 
Some-
what 
Disagree 
Neutral 
Some-
what 
Agree 
Strongly 
Agree 
The Mobility+ system is easy to 
use  
The Mobility+ system is easy to 
carry  
The silent nature of The 
Mobility+ system during use is 
acceptable 
The Mobility+ allows me to feed 
discreetly 
I am satisfied with the overall 
performance of the Mobility+ 
system  
Note to operator: When scoring this questionnaire, assign points using the legend below. 
Strongly Disagree = 0 points, Somewhat Disagree = 1, Neutral = 2, Somewhat Agree = 3 and Strongly 
Agree = 4 
Do you experience any of the 
following symptoms of feed 
intolerance while on your 
current feeding system? 
Gas/Bloating? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Abdominal Pain? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Diarrhea? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Constipation? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Nausea/Vomiting? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Reflux? 
☐Yes
☐No
If yes, is it mild, moderate, or 
severe? 
Mild   
☐ 
Moderate 
☐ 
Severe 
☐ 
Have you been admitted to 
hospital since you last received 
phone communication?   
☐Yes
☐No
General End of Study Questions: 
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When answering the following questions, consider how the last 14 days with Mobility+ have been 
compared to an average week of using the feeding system that you had before you started this study. 
Please try to answer based solely on your experience with the Mobility+ in the last two weeks and 
not on external factors that may have positively/negatively impacted your week of using the Mobility+ 
How do you feel your overall Quality of Life has been during the last 2 weeks of using Mobility+? 
Excellent 
☐ 
Good 
☐ 
Neutral 
☐ 
Bad 
☐ 
Very Bad 
☐ 
How mobile have you been in your everyday activities during the last 2 weeks of using 
Mobility+, compared to before you started the study? 
Much Better 
☐ 
Somewhat Better 
☐ 
About the Same 
☐ 
Somewhat Worse 
☐ 
Much Worse 
☐ 
How do you rate the importance of being mobile in your everyday activities to your overall wellbeing? 
Very Important 
☐ 
Somewhat important 
☐ 
Not important at all 
☐ 
How strongly do you agree with the following statement? I would like to use the Mobility+ again. 
Strongly Agree 
☐ 
Somewhat Agree 
☐ 
Neutral 
☐ 
Somewhat 
Disagree 
☐ 
Strongly Disagree 
☐ 
If you would like to use Mobility+ again, how often would you like to use it? 
Every Day 
☐ 
Every Week 
☐ 
Every Month 
☐ 
Think about your overall wellbeing if you used Mobility+ for SOME/ALL of your tube feeding needs, in 
the long term. How would your wellbeing be then, compared to now? 
Much Better 
☐ 
Somewhat Better 
☐ 
About the Same 
☐ 
Somewhat Worse 
☐ 
Much Worse 
☐ 
Would you pay out of pocket for the Mobility+? 
YES 
☐ 
NO 
☐ 
How did you choose to wear the Mobility+ system? 
☐Crossbody bag
☐Handbag
☐Backpack
☐In clothing
☐Clipped onto belt/clothing
☐ Other (Detail): ………………………………………………………………………………… 
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Appendix 8 
Appendix 8 - Phone communication check sheet (Study Day 7 and 14) - (Operator asks the 
Participant these questions) 
Day 7 
Day 7 
Questions: 
Answers: 
Day 7 Safety & Effectiveness Check 
Are you able to use Mobility+ to successfully and safely provide enteral 
feeding? 
   YES 
   ☐ 
  NO 
   ☐ 
Day 7 Compliance & Calorie Intake Check 
Consider your feed intake over the last 3 days (i.e. Study day 4, 5, 6). 
Questions: 
Answers: 
What volume of enteral nutrition did you consume on average per day 
(i.e. over 24 hr)? 
Volume 
Mobility+ 
…………mls 
Volume Other 
System 
…………mls 
How many hours did you typically infuse for, on average/day? 
   ……… hours    ………. minutes 
How many feedings did you intend to take using Mobility+, on average 
/ day? 
…………feedings 
How many feedings were you able to take using Mobility+, on average 
/ day? 
…………feedings 
What was the average volume of enteral nutrition that you consumed 
per feeding with Mobility+? 
…………mls 
What time of the day did you provide feedings with Mobility+? 
Morning ☐  
Afternoon ☐ 
Evening ☐ 
Night-time ☐ 
Operator facing 
question: 
On average, did the participant take at least two
daily feeds with Mobility+? 
   YES 
   ☐ 
  NO 
   ☐ 
If no, why not? 
……………… 
Day 7 Tubing SKU check 
Study Day 7:  
SKU that participant is using: 
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐
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Select one: 
Stay on this SKU 
☐ 
Trial ___________ SKU 
☐ 
Reason for changing: 
Intolerance ☐ 
Taking too long to feed ☐ 
Abdominal discomfort☐ 
Unable to tolerate feed☐ 
Day 14 
Day 14 Tubing SKU Check 
What giving set tubing are you using? 
440mm 
RED 
☐ 
700mm 
BLUE 
☐ 
1000mm 
GREEN 
☐ 
1900mm 
WHITE 
☐ 
Day 14 Safety & Effectiveness Check 
Are you able to use Mobility+ to successfully and safely provide 
enteral feeding?  
   YES 
   ☐ 
  NO 
   ☐ 
Day 14 Compliance & Calorie Intake Check 
Consider your feed intake over the last 3 days (i.e., Study Day 11, 12, 13). 
What volume of enteral nutrition did you consume on average per day (i.e. over 
24 hr) 
Volume 
…………mls 
Volume 
Other 
System 
…………mls
How many hours did you typically infuse for, on average/day? 
……… 
hours 
………. 
minutes 
How many feedings did you intend to take using Mobility+, on average 
/ day? 
…………feedings 
How many feedings were you able to take using Mobility+, on average 
/ day? 
…………feedings 
What was the average volume of enteral nutrition that you consumed 
per feeding with Mobility+? 
…………mls 
What time of the day did you provide feedings with Mobility+? 
Morning ☐ 
Afternoon ☐ 
Evening ☐ 
Night-time ☐ 
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Operator facing 
question: 
On average, did the participant take at least two
daily feeds with Mobility+? 
   YES 
   ☐ 
  NO 
   ☐ 
If no, why not? 
………………… 
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Appendix 9 
Adverse event classifications 
The below figures from ISO 14155:2020 highlight the process to be followed to determine if 
an AE or device deficiency is one of the below:  
•
AE
•
SAE
•
ADE
•
SADE
•
ASADE
•
USADE
•
Device deficiency with SADE potential
•
Device deficiency without SADE potential
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Appendix 10 
Adverse Events Logging Method 
The PI undertakes to report serious matters in a timely manner (within 24 hours) to the sponsor 
including details on the below: 
•
Participant ID
•
Operator ID
•
Incident date and time
•
Incident details  Incident category
•
PI assessment details
•
Determination
•
Action
•
Time PI reported assessment to Sponsor
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Appendix 11 
Participant Familiarization Training 
This familiarization training matches typical training provided for new users of new enteral feeding 
systems on discharge and consists of a 1:1 demonstration of the system, including bringing attention 
to the labelling of the system, to minimize the potential for user errors to occur during unsupervised 
home use . Participants will attend a short 1:1 training session with a trained operator where they will 
be trained on Filling Method A (Filling from feed poured into a container), flushing, feeding, and 
wearing, as below. The setting will be a room in a clinical environment.  
•
Provide participant with Instructions for Use (IFU) booklet, a Mobility+ feeding pouch, giving
set tubing, filling-set tubing, an ENFIT syringe and a cross-body bag
•
Inform participant of the option to consult an instructional video, which can be accessed via
smart device by scanning QR code on the IFU
Filling 
•
Demonstrate Filling Method A steps by filling a pouch with some water or formula.
Feeding 
•
Demonstrate ‘feeding’ by letting the Feeding Pouch (with giving-set attached) deliver some of
its contents into a beaker.
•
Explain the Feeding pouch deflates and reduces in weight as liquid feed is delivered , and the
feed session is finished when no more liquid flows out of the tubing
•
Advise the participant they can hold their Feeding pouch at times during feeding, to get used
to feeling the pouch deflating and reducing in weight
Flushing 
•
Take the participant through the flushing section of the IFU
Wearing 
•
Show the participant the IFU guidance on how to loosely coil the giving set tubing and advise
them to place the giving set tubing in the bag/clothing they choose to wear the system in
(without kinking the tubing).
Hazards 
•
Ensure the participant is aware of the warning statement and precautions in the IFU
Notes: 
•
Extension set tubing may be left outside any bag/clothing the device is being worn in
•
The Feeding Pouch is not to be squeezed during set up or use. The only time it is appropriate
to squeeze the pouch is during flushing
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Appendix 12 
Participant familiarization training record 
Date………….. 
Participant ID/……………… 
Operator ID……………………. 
Familiarization training was conducted and the participant was taken through filling (filling 
method A), feeding, flushing, and wearing, as per the Instructions for Use, and given 
opportunity to execute the steps necessary for them to use the Mobility+ system at home to 
obtain their necessary nutrition.  
Participant Signature …………………… 
Operator signature ……………………….. 
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Appendix 13 
Operator training record 
Date………….. 
Operator ID……………………. 
Operator self- training on use of Mobility+ device was conducted. 
Operator was trained in execution of this study protocol (CLP001) by the sponsor Rockfield 
Medical Devices.  
Operator signature ……………………….. 
Sponsor signature ........................ 
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Appendix 14  
Evidence of Expert review 
The below specially developed surveys and other study tools are the subject of expert review, 
which will be recorded in the format of a short report/letter.   
Surveys being expertly reviewed for validation: 
Participant perspectives surveys: 
•
Participant perspectives baseline survey (Appendix 4)
•
Participant perspectives outcome survey (Appendix 7)
Tools being expertly reviewed for general suitability for use: 
•
Quality of Life measure (Appendix 5)
•
Mobility+ flow rate guide (See LA030 attached to protocol)
•
Phone communication check sheets (Trial days – Appendix 6)
•
Phone communication check sheets (Study days 7 and 14 - Appendix 8)
•
General end of study questions (end of Appendix 7)
•
Giving set decision trees (Figures 6 and 7
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