Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
Phase: NA
Conditions: Feeding Tube, Dysphagia
Sponsor: Fidmi Medical

 
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Date of Protocol Version:   Ver5.1;  20/Mar/2018   
 
 
Sponsor:  Fidmi Medical Ltd. 
  
 
 
Principal Investigator:  Dr. Dov Wengrower,  
Director, Therapeutic Endoscopy Unit. Digestive 
Diseases Institute  
Shaare Zedek Medical Center, Jerusalem 
 
FIDMI MEDICAL LTD. 
5 HAESHEL STREET, CAESAREA, 
P.O. 3079500 
P.O. 3079815 
ISRAEL 
Webpage: www.Fidmimedical.com 
 
 
 
 
 
 

 
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REVISION HISTROY TABLE 
 
REVISION 
NUMBER 
REASON FOR CHANGE 
DOCUMENT AUTHOR 
RELEASE DATE 
1 
Initial release.  
Tal Lavi, GSAP 
medical Ltd. 
19/Dec/2016 
2 
a) Better Specifying patients indication for 
Inclusion: "oropharyngeal dysphagia 
impairing or anticipated to impair the 
patients' nutritional status"  
b) 
specifying "visit in patient facility" to be 
performed by sub-investigator  
c) 
GERD abbreviation typo + adding IFU to the 
abbreviation 
d) 
Adding version control to the PI signature 
page 
e) 
'V7' instead of 'V5' typo in the Schematic of 
study design 
f) 
Changing Early withdraw criteria 9.2.3.6 to 
"Inability to complete Fidmi device 
gastrostomy placement" 
g) 
Adding Packaging, Labeling and Storage (5.4) 
h) 
Visit 1 can be performed up until 2 weeks before 
insertion procedure 
i) 
Elaborating Intended Use (5.3) to subjects with 
functioning digestive system 
j) 
Adding to the procedural tasks that the patient 
would be instructed by the staff with the home 
Instructions to Use (10.1.1) 
k) 
Un-merging the PEG Insertion/Removal Form into 
two separated forms(10.1.1) 
l) 
Update of 'Visits Procedure Chart' per current 
protocol (X-ray imaging) 
m)  Adding "Apotropos signed authorization 
documents (when applicable)" to the 
required Source Documents list (13.5.2) 
n) Adding further elaborations on "screen 
failure subjects" (9.3.1) 
Tal Lavi, GSAP 
medical Ltd. 
14/Feb/2017 
3 
a) Adding elaboration in case a Gastrostom 
replacement (10.1.2, Visit 6) 
b) Adding to follow-up visits 6 &7 (10.1.2) that: 
*An endoscopic examination is not required 
but may be performed on a need base, and 
following the investigator discretion. 
Tal Lavi, GSAP 
medical Ltd. 
23/Apr/2017 
4 
Changing inclusion age criteria from 80 to 90 
years old to increase patient potential for 
the study  
Keren Smulovitz, 
GSAP medical Ltd. 
29/May/2017 

 
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REVISION 
NUMBER 
REASON FOR CHANGE 
DOCUMENT AUTHOR 
RELEASE DATE 
4.1 
Adding Shaare Zedek Medical Center to the 
study (multi-site study) 
Tal Lavi, PhD 
GSAP medical Ltd. 
20/Nov/2017 
5.1 
Adding an option to Home abdominal X-ray 
evaluation at visit 7 – performed by Medix at 
Home, phone call follow up 
Tal Lavi, PhD 
Gsap medical Ltd. 
20/Mar/2018 
 
TABLE OF CONTENTS 
 
 
Page 
1. 
SIGNATURES 
4 
2. 
LIST OF ABBREVIATIONS 
5 
3. 
PROTOCOL SYNOPSIS 
5 
4. 
SCHEMATIC OF STUDY DESIGN 
11 
5. 
INTRODUCTION – BACKGROUNG AND DEVICE DESCRIPTION 
11 
6 
POTENTIAL RISKS AND BENEFITS 
21 
7 
TRIAL OBJECTIVE AND HYPOTHESIS 
22 
8 
TRIAL DESIGN 
23 
9 
SELECTION AND WITHDRAWAL OF SUBJECTS 
25 
10 
TRIAL PROCEDURES 
29 
11 
SAFETY ASSESSMENT 
38 
12 
STATISTICAL ANALYSIS 
44 
13 
INVESTIGATION ADMINISTRATION 
45 
14 
REFERENCES 
51 
 
 
 
 LIST OF TABLES 
TABLE 1– COMPARISON OF EXISTING TECHNOLOGIES .......................................................................... 14 
TABLE 2 – SPECIFICATION ....................................................................................................................... 15 
TABLE 3 - VISIT PROCEDURE CHART ...................................................................................................... 39 
 
LIST OF FIGURES 
FIGURE 1 - FIDMI DEVICE ....................................................................................................................... 15 
FIGURE 2 – FIDMI DEVICE MODEL .......................................................................................................... 16 
FIGURE 3– FIDMI DEVICE INSERTION ..................................................................................................... 17 
FIGURE  4  - AE DEFINITION (ADE- ADVERSE DRUG EVENT, SADE-SERIOUS ADVERSE DEVICE EVENT) ... 43 
 
 
 
 

 
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1. SIGNATURES 
 
 
 
Sponsor Signature: ________________________ 
 
Date: ____________ 
 
 
 
Principal Investigator Agreement: 
I have carefully read and understood the provisions of this protocol – Version5.1 
___and I am prepared to follow them in every detail in the conduct of this study. 
 
 
Principal Investigator Signature: _____________ Date: ____________ 
 
 
 
 
 

 
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2. LIST OF ABBREVIATIONS 
Abbreviation 
Name 
AE 
Adverse Event 
BMI 
Body Mass Index 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
ER 
Emergency Room 
GERD 
Gastroesophageal Reflux Disease 
ICF 
Informed Consent Form 
IFU 
Instructions For Use 
INR 
International Normalised Ratio 
IRB 
Institutional Review Board 
GI 
Gastrointestinal 
MOH 
Ministry of Health 
NA 
Not Available 
PEG 
Percutaneous Endoscopic Gastrostomy 
PI 
Principal Investigator 
 
 
 
 
 
 
 
3. PROTOCOL SYNOPSIS 
 
Protocol Number FM-01 
Protocol Title 
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding 
Device 
Participating 
Countries 
IL 
Study Type 
Interventional  
 
Study Design 
The Fidmi trial is an early First In Human feasibility Open Label single 
center study consists of Single Group Assignment, to evaluate the safety 
and preliminary efficacy of Fidmi Low-Profile Enteral Feeding Device as a 
treatment for adult patients with a need for enteral feeding 
(Percutaneous Endoscopic Gastrostomy placement). 
Investigational 
Study Device  
Fidmi Feeding Device,  by Fidmi Medical Ltd. 

 
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Study Purpose 
To evaluate the safety and effectiveness of the Fidmi PEG device: 
insertion, long term utilization, dismantling and removal  
Study Population 
15 adult patients, male or female suffering from dysphagia, who are 
scheduled for PEG (Newly PEG insertion (minimum 10 patients) and PEG 
replacement involving endoscopy procedure) 
Study 
Procedures 
 
15 Consecutive adult patients with need for enteral feeding Scheduled for 
PEG with protocol sedation. The patients will attend the following: 
Visit 1: Screening and Enrollment 
Visit 2: Insertion or replacement in the Endoscopy suite,  
Visit 3: Follow up after 2 days (sub-investigator visit in patient facility) 
Visit 4: Follow up after 1 month (sub-investigator visit in patient facility) 
Visit 5: Follow up after 2 month (phone call) 
Visit 6: Follow up after 3 months and Fidmi device removal 
Visit 7: Follow up after 4 months, X-ray and termination 
Study Endpoints 
Safety Endpoints: 
1. Number of Participants With Treatment-Related Adverse Events as 
Assessed by CTCAE v4.0 through study completion.   
2. Number 
of 
participants 
requiring 
unscheduled 
hospital 
readmission related to Fidmi Feeding device through study 
completion. 
Performance Endpoints:  
Primary: 
3. Number of accidental dislodgements during study follow up until 
device removal at 3 months. 
4. Number of unscheduled internal tube replacements (only clogged 
tubes) until device removal at 3 months. 
5. Patient Pain on the Visual Analog Scale during device removal at 3 
months. 
6. Number of uneventful (flawless) insertions and removals of Fidmi 
PEG device during device placement (Day 0) and device removal (3 
month). 
Secondary: 
7. Device placement procedure time length at Day 0 (from 
endoscope intubation to end of procedure).  

 
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8. Ease of the device placement procedure (Scored by the investigator 
performing the procedure using the 10-point Visual analogue scale 
satisfaction) at Day 0. 
9. Ease of the device removal procedure (Scored by the investigator 
performing the procedure using the 10-point Visual analogue scale 
satisfaction) at 3 months. 
10. Ease of the internal tube replacement (Scored by the 
patient/caregiver) using the 10-point Visual analogue scale 
satisfaction) until device removal at 3 month. 
11. Validate (True/False) correct (color) selection of 'Measuring 
Cannula' at Day 0 by residual tube measurement [design endpoint] 
Study 
Methods 
of Appraisal  
 
Safety assessment  
Safety assessment will be based upon monitoring the Adverse events, 
which will be collected throughout the trial (placement, chronic utilization,  
removal procedure and post removal follow up) 
Adverse events encountered will be reported as categorized below in 
accordance with reviewing Ethics Committee and Competent authority 
requirements. 
 
Complication 
 
Placement complication: excessive stoma wound bleeding, over tightened 
external bumper, gastric and/or esophageal laceration, device unintended 
disassembly, need for more than one needle puncture 
 
Short-term complications (post placement) [ Time Frame: 1week ] [ 
Designated as safety issue: Yes ] 
Stomal 
complication 
(wound 
infection, 
peristomal 
leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external 
bumper). 
Tube complication (accidental dislodgement, tube leakage, buried 
bumper, gastric outlet obstruction, dumping syndrome). 
 
Long-term complications [ Time Frame: 3 month ] [ Designated as safety 
issue: Yes ] 

 
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Stomal 
complication 
(wound 
infection, 
peristomal 
leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external 
bumper). 
Tube complication (accidental dislodgement, tube leakage, buried 
bumper, gastric outlet obstruction, dumping syndrome). 
 
Post removal  complication 
Bowel obstruction, Bowel peroration, GI bleeding, painful defecation  
 
 
USIBILITY STUDY MEASURES  
 
Placement 
1. Procedure time length (from endoscope intubation to end of 
procedure).  
2. Difficulty of the procedure in general compared to routine 
procedure [Time Frame: Intra-procedural] Scored by the 
endoscopist on a 10-point Visual Analogue Scale). 
3. Endoscopic measurement – clear, simple and decisiveness of color 
scale evaluation, accurate length estimation.  
4. Need for additional needle puncture (sheath kink, loss of 
visualization).   
5. Ease of device insertion through the esophagus [questioner]. 
6. Ease of tube exteriorization through abdominal wall [questioner]. 
7. Placement location in the gastric body (low (pre pyloric) mid, high). 
8. External bumper connection - Tactile feedback, confidence in 
secured connection [questioner]. 
9. Measurement and evaluation of the Residual Tube at the end of the 
procedure – ensure residual is not "over protruding". 
 
Post placement utilization. [Time Frame: 3 months] 
10. Patency of disposable tube (partial or clogged tubes).   
11. Disposable tube performance (ease of replacement, jammed tube, 
leakage). 
12. Patency of the affixed main tube which is defined as time period 
between device placement and need for re-intervention (e.g. - 
flushing). 
13. Measurement and evaluation of the Residual Tube at follow up visits 
– ensure residual is not "over protruding". 
14. Patient discomfort during long term use (Granulation tissue at the 
insertion site, limitation, esthetic etc.) 
 

 
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Removal  
15. Dismantling - tactile feedback (Obvious, vague scale). 
16. Force needed for bumper-less shaft extraction compared to 
standard skin level removal of collapsible bumper graded: similar 
harder, lighter, much lighter, negligible (comparable to endoscope 
withdraw from esophagus. 
17. Patient discomfort during the procedure. 
  
Bumper flanges expulsion 
18. Sensation in communicating patients. 
 
Inclusion/ 
Exclusion Criteria 
Inclusion Criteria: 
1. Male or female patient 18 up to 90 years. 
2. Consecutive adult patients suffering from oropharyngeal dysphagia 
impairing or anticipated to impair the patients' nutritional status 
with need for enteral feeding (PEG).  
3. Ability to give informed consent for the study by patient or legal 
guardian. 
4. Willingness to undergo 4 follow up visits 1, 3 and 4 months 
following PEG insertion/replacement, as well as unscheduled sick 
visits. 
 
 
Exclusion Criteria: 
1. Pregnancy (all women of child-bearing age would be questioned 
and told by the consenting physician regarding that criteria). 
2. All current practice PEG contraindication 
3. Acute gastrointestinal bleeding 
4. Extreme obesity patients (BMI>40) 
5. Emergency endoscopy 
6. Infectious disease local or systemic (e.g.- sepsis, pancreatitis) 
7. Known esophageal pathology  (e.g.- stenosis, eosinophilic 
esophagitis, varices,  achalasia, reflux) 
8. In case of PEG replacement: lack of a well healed gastrostomy or 
Infection around the insertion site. 
9. Known gastric pathology that may prevent safe device insertion, 
feeding, removal and Bumper flanges expulsion according to the 
investigator discretion.  
10. Any history of bowel obstruction, pseudo-obstruction. 
11. Crohn's disease 

 
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12. Severe GERD, recurrent vomiting  
13. Inability to tolerate sedated upper endoscopy due to cardio-
pulmonary instability or other contraindication to endoscopy 
14. Current enrollment in an investigational drug or device study or 
participation in such a study within 30 days of entry into this study. 
 
Study Duration 
Per Patient: between 120 days±14 days, depending on the interval 
between pre-operative visit (inclusion) and day of operation. 
Total 8 months to recruit and treat 15 patients. 
Statistical 
Analysis Plan 
NA. Feasibility safety study. 
Descriptive statistics will be provided. 
 
 
 

 
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4. SCHEMATIC OF STUDY DESIGN 
 
 
 
5. INTRODUCTION – BACKGROUNG AND DEVICE DESCRIPTION  
5.1 BACKGROUND & GENERAL DESCRIPTION 
 
Over 17.6 million stroke, Parkinson’s, cancer and multiple sclerosis patients have poor control 
over their swallowing muscles and are unable to safely consume enough food. This swallowing 
disorder is called dysphagia. If untreated dysphagia can lead to aspiration pneumonia - food 
leakage into the lungs, which can even cause death. In addition, patients may require a long-
term (for years) solution for feeding to deliver nutrition, liquids and medications directly into 
the stomach. 
The type of feeding tube and its placement depends on various factors, including the patient’s 
clinical condition and the length of time enteral feeding is needed (1). There are two 
categories of enteral feeding tubes: nasoenteric and enterostomy tubes. Nasoenteric tubes 
are placed either nasally or orally, typically in patients requiring short-term nutritional 
support, usually for less than 30 days. Enterostomy tubes are placed into the stomach or small 
bowel through an incision in patients requiring nutritional support over an extended period 
of time, usually greater than 30 days. The enterostomy feeding tubes can be divided into two 
Screening & 
Enrollment
Fidmi 
device 
insertion
Follow Up 
Period
V1 
V2  
Day 0 
V3 
 Day 2 
V4  
Day 30 
V5 
 Day 60 
V6 
Day 90 
V7 
Day 120 
 
Baseline 
visit in patient 
facility 
visit in patient 
facility 
Follow Up call 
with the 
patient 
Fidmi device 
removal/ 
replacement 
X-ray and 
termination 
visit 

 
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main groups: Gastrostomy tubes, placed into the patient’s stomach; and Jejunal feeding tubes, 
placed into the duodenum or proximal jejunum using a variety of techniques.  
Currently, the most common enteral Gastrostomy feeding is obtained through Percutaneous 
Endoscopic Gastrostomy (PEG) tubes. The initial placement is performed with the help of an 
endoscope that ensures correct positioning in the stomach. The PEG tube passes through the 
skin of the abdomen in an opening called stoma, and it is held in place by a semi-rigid bumper. 
PEG tubes are increasingly used for enteral feeding procedures, although they are troubled by 
several shortcomings:  
 
Problem #1: Frequent dislodgement. During their total lifetime, 12.8% cases (2) of PEG tubes 
with soft inner bumper undergo accidental dislodgement, as patients may pull out the tube 
or the long tubing is displaced during patient transfers, physical therapy or by catching on 
sheets or bed railings. If a PEG tube is dislodged prior to the tract maturation, specifically 
within the first 30 days after initial placement, then an emergency intervention is required to 
recover the stoma. Complications within the procedure are likely to affect the stomach that 
can separate from the abdominal wall with the open gastrostomy leaking gastric contents into 
the peritoneal cavity. Delayed dislodgements have to be treated with the PEG tube being 
reinserted urgently (within the next 12 hours) to prevent the abdominal stoma from closing. 
The procedure must be undertaken in the hospital, adding workload to the patients and the 
healthcare system. PEG pull-outs require an emergency department visit, a level 3 surgical 
procedure, a replacement gastrostomy tube, and a radiographic confirmation of tube 
positioning. (2).  
 
Problem #2: Difficult replacement. Physicians recommend changing standard PEG tubes after 
an average period of 6 months. The replacement is performed in a hospital room by pulling 
out the tube. It is a very painful and unpleasant procedure. Internal bumpers are not very soft 
to avoid issues with dislodgement and therefore the “pull” technique” is harmful and risky for 
patients. In 7.6% of cases, there are major complications such as gastrointestinal (GI) tract 
perforation (3) which can lead to peritonitis, infection, GI bleeding. Minor complications such 
as stoma leaking and bleeding, and skin dermatitis arise in 24% of replacement cases (4). 
 

 
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Problem #3: Tube clogging. Obstruction is a common complication of enteral tube feeding. 
PEG tubes become clogged during their lifetime in approximately 45% cases (5) due to 
difficulties in cleaning and flushing the inner cavity properly. Tube clogging happens slowly, 
and progressively increases the duration of the feeding from 10 minute up to 1 hour. In 
addition, this has unpleasant and frustrating consequences for the patient and the caregiver, 
and compromises nutrient delivery.  
 
 
Currently there are many solutions in the market for long-term enteral feeding, however none 
of them provide comfort and autonomy to their users, since they have a high probability of 
dislodgement, clogging, leakage and are bulky: 
 
i. 
Standard PEG tubes suffer from the paradox requirement of the inner bumper that 
should be both rigid to hold the device in place and soft to enable an easy removal by 
traction, avoiding injury to the patient. As a result, to avoid the risk of internal injury, 
traditional PEG tubes are subject to dislodgment. Moreover, these are long tubes that 
easily clog and are uncomfortable for the patient as they may be pulled out during 
transfers, physical activities, or caught on sheets and bed railings. Physicians 
recommend replacing PEG tubes after 6 months to prevent complications.  
ii. 
Standard Gastronomy tube (replacement): tubes with balloon bumpers are subject 
to dislodgement, as they can deflate, rupture, burst or leak. This implies an 
emergency intervention since the device should be replaced within 6-12 hours to 
prevent the stoma from closing and avoid a repeat PEG procedure. The lifespan is only 
3 months, and the replacement procedure needs to be performed in hospitals.  
iii. 
Replacement devices, that are either gastrostomy tubes or low-profile devices, can 
be inserted only after PEG tract is matured (3 months after initial placement). The 
time of use is up to 3 months, and the replacement procedure needs to be performed 
in hospitals. The tube is retained by an internal bumper consisting either of an 
inflatable balloon or of a non-balloon collapsible bumper. Retention balloons allow 
easy tube removal and eliminate the risk of tract perforations from rigid bumpers. 

 
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Non-balloon bumpers are more difficult to insert and remove and may easily dislodge 
due to collapsible, small, dome-shaped bumper.  
  
Table 1– Comparison of existing technologies 
 
A major drawback of the current marketed solutions is the short time of use, 13% of the tubes 
are dislodged unexpectedly (6). Other replacements occur due to defective valves, shafts and 
ruptured balloons or bumpers. Consequently, the annual price of the device is significantly 
increased, and secondly patients can suffer from some serious complications: mucosal or 
tissue injury. Estimates of the incidence of clogged feeding tubes range widely, from 12.5-45% 
over the life of the existing tubes (7). 
5.2 DEVICE DESCRIPTION 
 
Fidmi device is an enhanced enteral feeding device that stays securely in place and maintains 
tube patency during treatment. Fidmi presents a discrete feeding device for patients suffering 
from dysphagia. Fidmi Device is the first presented "low-profile device from day 1", easily 
hidden under clothing and not limiting mobility. Unlike other solutions, Fidmi device is 
resistant to dislodgement due to a semi-rigid internal bumper, and avoids clogging thanks to 
a disposable insert to deliver the nutrition. Video: http://www.Fidmimedical.com/peg-device-
for-initial-placement  
Fidmi device consists of 1) a rigid-core silicone bumper that prevents dislodgment, 2) a 
disposable internal tube replacement for a daily nutrition supply and prolonged patency, and 
3) an external flexible bolster that keeps the stoma site ventilated and stable. The disposable 
insert is placed inside the feeding port and is replaced every 1-2 weeks to avoid clogging, 

 
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extend the product life, and improve the cleanliness and hygiene of the tube. Disposable tube 
replacement is easy and safe and can be done by the patients themselves or their caregivers 
as the tract is never compromised and there is no need for a physician verification. The device 
is eventually removed in a simple procedure that can be done by the caregiver or patient 
himself. Fidmi device a tool dismantles the internal bumper into small parts that are naturally 
expelled from the body for trauma free-removal (Figure 1 right panel). 
Figure 1 - Fidmi device  
 
Product: Fidmi Medical boasts a comprehensive solution for initial placement, replacement, 
and complete removal of PEG tubes. Fidmi device is a low-profile cosmetic design internal 
feeding device that simplifies the tube insertion, maintenance and improves the patient 
mobility. It is discrete, so can be easily hidden under clothing. Fidmi device specifications are 
provided in Table 2. 
 
Table 2 – Specification 
 
Figure 1. Fidmi device 

 
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The device consists of three main parts (Figure 2):  
i. 
The internal bumper is rigid enough to prevent dislodgment during the normal use 
and stay in place from the initial insertion.  
ii. 
The disposable feeding tube is used to supply nutrition to the patient. It’s 
recommended to be replaced each 2 weeks by the patient or caregiver without 
removing the feeding device.  
iii. 
An external flexible port is attached to the tube, allowing easy access for daily care. 
The device itself does not require replacement and therefore the abdominal tract and 
the stoma opening are never stressed or compromised. The feeding port has a 
comfortable and ventilated design that protects the stoma and holds the disposable 
feeding insert in place.  
 
Figure 2 – Fidmi device model 
 
 
5.3 INTENDED USE AND INDICATIONS FOR USE 
 
Fidmi device is intended to provide nutrition to a patient directly into the stomach through a 
stoma. The Fidmi PEG device would be investigated in this study on patients suffering from 
oropharyngeal dysphagia impairing or anticipated to impair the patients' nutritional status, 
who are scheduled for PEG procedure in order to improve surgical initial insertion, device 
replacement and removal. Enteral feeding is used in patients who have functioning digestive 
systems, but are unable to orally ingest adequate nutrients or to meet their metabolic needs. 

 
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Fidmi provides the first PEG device with a discrete enteral feeding solution from Day-1 that 
overcomes most of the currently suffered shortcomings. Fidmi device can ensure less 
complications, less follow-up visits, 5 minute replacement, 2 year lifetime.  
The device is inserted in a standard PEG procedure and the whole insertion takes up to 45 
minutes: a physician places the feeding tube into a patient mouth (a) using the Fidmi device 
kit – a retrieval snare (Figure 3). The feeding tube is inserted through an incision in the 
abdomen (d). The internal bumper stops the tube from falling out (e). It rests in the stomach 
and exits through the skin. The external bolster is then connected allowing an external fixation 
and stability (f). These features eliminate the need of repeatable replacement of the PEG, 
reduce clogs and allow medications or nutrition to flow freely. The replacement takes an 
approximate time of 5 minutes. The unique design stabilizes the device and keep it clean and 
ventilated. When enteral feeding is no longer required, the device is easily removed: the 
patient or caregiver pushes the internal bumper using Fidmi device kit, then the internal 
bumper breaks into 5 pieces that fall into the stomach and naturally expel from the body. The 
feeding tube and port are easily and safely pulled out allowing the tract to close. 
 
Figure 3– Fidmi device insertion 
 
Additional preclinical results are detailed in the Investigator brochure.   
 

 
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5.4 Packaging, Labeling and Storage  
 
5.4.1 Packaging and Labeling 
Packaging and labeling of Fidmi Feeding device (study Investigational Medicinal 
Product) will be performed in compliance with relevant regulatory requirements of 
GMP guidelines. 
Further details are elaborated in the Investigational Brochure. 
 
In order to be delivered ready for use each 'Patient Pack' are assembled with:  
• 
1X Measurement pack (Fidmi Medical Stoma Measuring Device), packed in a heat 
sealable EtO compatible sterilization pouch 
• 
1X Placement and Feeding pack (Fidmi Medical Enteral Feeding Device), sealed in a 
rigid tray PET-G blister pack with a Tyvek® lid (heat pressed) 
• 
5X Disposable Tube Pack (Replaceable Tube Pack), sealed within a rigid tray blister 
pack with a Tyvek® lid 
• 
10X Extension tubes.  
Packs are plug-sealed and packed in adhesive-sealable wrap packaging pouches/blister pack. 
These are sealed and labeled with the patient details and expiry time. Device packs are 
transferred to the site for the clinical usage according to the study protocol. 
 
Illustration samples of Device Package Labels:  
 
Fidmi Medical Stoma Measuring Device,  
Version: _____________ UDI : CT…_____________ 
Sponsor: Fidmi Medical Ltd., 17 Tchelet St. Misgav, Israel  
For clinical trial use only 
Instruction for Use and Warnings are enclosed inside the kit 
0297-17-SZMC Shaare Zedek Medical Center, Dr. Dov 
Wengrower. 
Trial subject ID ______  
Storage conditions: Temperature: - 30º C – (+60º C), Humidity: ≤ 
90%, Do not store device in direct sunlight 
Keep out of reach of children 

 
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Fidmi Medical Enteral Feeding Device,  
Version: _____________ UDI : CT…_____________ 
Sponsor: Fidmi Medical Ltd., 17 Tchelet St. Misgav, Israel  
For clinical trial use only 
Instruction for Use and Warnings are enclosed inside the kit 
0297-17-SZMC Shaare Zedek Medical Center, Dr. Dov 
Wengrower. 
Trial subject ID ______  
Storage conditions: Temperature: - 30º C – (+60º C), Humidity: ≤ 
90%, Do not store device in direct sunlight 
Keep out of reach of children 
 
 
 
Replaceable Tube Pack,  
Version: _____________ UDI : CT…_____________ 
Sponsor: Fidmi Medical Ltd., 17 Tchelet St. Misgav, Israel  
For clinical trial use only 
Instruction for Use and Warnings are enclosed inside the kit 
0297-17-SZMC Shaare Zedek Medical Center, Dr. Dov 
Wengrower. 
Trial subject ID ______  
Storage conditions: Temperature: - 30º C – (+60º C), Humidity: ≤ 
90%, Do not store device in direct sunlight 
Keep out of reach of children 
 
 
 
 פידמי
מכשיר מדידת הסטומה 
גרסה_____________________:מספר מזהה________
 
 היזם: פידמי מדיקל בע"מ, רחוב תכלת17, משגב, ישראל 
לשימוש בניסוי רפואי בלבד 
הוראות שימוש ואזהרות למשתמש מצורפים בערכה 0297-17-SZMC 
 .
 ,
 מרכז רפואי
שערי צדק", ד ר דב ונגרובר 
_____________ מספר נבדק 

 
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תנאי אכסון ': טמפ- 30º C – (+60º C)
 
< לחות90%
 , אין להניח תחת שמש
ישירה 
להרחיק מהישג ידם של ילדים 
 
 
פידמי מכשיר הזנה תוך בטנית 
________גרסה:_____________________מספר מזהה 
 :היזם פידמי מדיקל בע"מ, רחוב תכלת17, משגב, ישראל 
לשימוש בניסוי רפואי בלבד 
הוראות שימוש ואזהרות למשתמש מצורפים בערכה 
0297-17
-
SZMC
 .
 ,
 מרכז רפואי
שערי צדק", ד
ר דב ונגרובר 
_____________ מספר נבדק 
תנאי אכסון ': טמפ- 30º C – (+60º C)
 
< לחות90%
 , אין להניח תחת שמש
ישירה 
להרחיק מהישג ידם של ילדים 
 
 
ערכת צינוריות החלפה 
________גרסה:_____________________מספר מזהה 
 היזם: פידמי מדיקל בע"מ, רחוב תכלת17, משגב, ישראל 
לשימוש בניסוי רפואי בלבד 
הוראות שימוש ואזהרות למשתמש מצורפים בערכה 
0297-17
-
SZMC
 .
 ,
 מרכז רפואי
שערי צדק", ד
ר דב ונגרובר 
_____________ מספר נבדק 
תנאי אכסון ': טמפ- 30º C – (+60º C)
 
< לחות90%
 , אין להניח תחת שמש
ישירה 
להרחיק מהישג ידם של ילדים 
 
5.4.2 Transport and Storage 
 
• 
Temperature: - 30º C – (+60º C), Humidity: ≤ 90% 
• 
Do not store Fidmi Feeding device and Replacement Tubes in direct sunlight 
• 
Place the Disposable Tubes in their box or in a safe, dry, cool place. 
6 Potential Risks and Benefits 
6.1 Known Potential Risks 
Complications from PEG tube placement can be classified as major or minor (8): 

 
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 Minor complications include: 
i. 
Wound infection,  
ii. 
Peristomal leakage, 
iii. 
Wound leakage,  
iv. 
Wound bleeding,  
v. 
Hemorrhage bleeding 
vi. 
Cutaneous or gastric ulceration,  
vii. 
Pneumoperitoneum,  
viii. 
Temporary ileus,  
ix. 
Aspiration 
x. 
Gastric outlet obstruction. 
xi. 
Clogging 
xii. 
Tube dysfunction 
Major complications include: 
i. 
Necrotizing fasciitis,  
ii. 
Esophageal perforation,  
iii. 
Gastric perforation,  
iv. 
Colocutaneous fistula,  
v. 
Buried bumper syndrome,   
vi. 
Inadvertent PEG removal. 
vii. 
Small bowel obstruction 
viii. 
Hepatic injury 
 
6.2 Known Potential Benefits 
Fidmi Device will provide simple initial insertion, home replacement and removal 
procedures and would contribute to improved life quality of the patient. 
Fidmi Device is the first presented "low-profile device from day 1", easily hidden under 
clothing and not limiting mobility.  
Fidmi Device overcomes most of the currently suffered shortcomings. Fidmi device can ensure 
less complications, less follow-up visits, 5 minute replacement, 2 year lifetime. 

 
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7 TRIAL OBJECTIVE AND HYPOTHESIS 
7.1 STUDY OBJECTIVES 
To evaluate the safety and effectiveness of the: insertion, long term utilization, 
dismantling and removal, as a treatment for adult patients with a need for enteral 
feeding (Percutaneous Endoscopic Gastrostomy). 
 
7.2 HYPOTHESIS 
 
Insertion of Fidmi PEG device will reduce complication rate, reduce tedious patient 
follow up visits at the hospitals and significantly shorten the time of replacement from 
currently 45 minutes (in average) to 5 minutes. Above all, Fidmi device lifetime will 
offer 2 years' time instead of the current 3-6 months. 
 
7.3 STUDY PARTICIPATION DURATION 
 
Overall, under the study protocol, each patient enrolled into the study will undergo a 
total of 7 visits including 4 follow-up visits during study duration of 120 days±14 days.  
 
7.4 STUDY DURATION 
 
15 patients will be enrolled to the study. We expect enrollment to occur over a 8-
month period and the data analysis period of time will be 1 month time. 

 
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8 TRIAL DESIGN 
 
8.1 STUDY DESIGN 
The Fidmi trial is an early feasibility Open Label single center study consists of Single 
Group Assignment, to evaluate the safety and preliminary efficacy of Fidmi Low-Profile 
Enteral Feeding Device as a treatment for adult patients with a need for enteral 
feeding (Percutaneous Endoscopic Gastrostomy placement). 
 
 
8.2 STUDY ENDPOINTS 
Safety Endpoints: 
1. Evaluate incidence of adverse events according to National Cancer Institute 
(NCI) Terminology Criteria for AE v4.0 common terminology criteria for AE. 
(CTCAE) during insertion, patient utilization or removal of Fidmi PEG device.  
2. Concomitant medications 
3. Physical examination (of insertion site). 
4. Unscheduled hospital readmission. 
Performance Endpoints:  
Primary: 
5. To evaluate accidental dislodgement during study follow up. 
6. To evaluate unscheduled replacement rate (only clogged tubes). 
7. To evaluate patient pain during removal. 
8. To evaluate of uneventful (flawless) insertion and removal of Fidmi PEG device. 
9.  The ability to provide prescribed (and not partial) enteral feeding throughout 
the study period.  
Secondary: 
10. To evaluate usability by Physician filling a user questionnaire. 
11. To evaluate usability by the patient or caregiver during long term use filling a 
user questionnaire. 

 
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12. To be able to validate correct (color) selection of 'Measuring Cannula' by 
residual tube measurement [design endpoint] 
 
8.3 USIBILITY STUDY MEASURES 
 
Placement 
1. Procedure time length (from endoscope intubation to end of procedure).  
2. Difficulty of the procedure in general compared to routine procedure [Time 
Frame: Intra-procedural] Scored by the endoscopist on a 10-point Visual 
Analogue Scale). 
3. Endoscopic measurement – clear, simple and decisiveness of color scale 
evaluation, accurate length estimation.  
4. Need for additional needle puncture (sheath kink, loss of visualization).   
5. Ease of device insertion through the esophagus [questioner]. 
6. Ease of tube exteriorization through abdominal wall [questioner]. 
7. Placement location in the gastric body (low (pre pyloric) mid, high). 
8. External bumper connection - Tactile feedback, confidence in secured 
connection [questioner]. 
9. Measurement and evaluation of the Residual Tube at the end of the procedure 
– ensure residual is not "over protruding". 
 
Post placement utilization. [Time Frame: 3 months] 
10. Patency of disposable tube (partial or clogged tubes).   
11. Disposable tube performance (ease of replacement, jammed tube, leakage). 
12. Patency of the affixed main tube which is defined as time period between 
device placement and need for re-intervention (e.g. - flushing). 
13. Measurement and evaluation of the Residual Tube at follow up visits – ensure 
residual is not "over protruding". 
14. Patient discomfort during long term use (Granulation tissue at the insertion site, 
limitation, esthetic etc.) 
 
Removal  
15. Dismantling - tactile feedback (Obvious, vague scale). 
16. Force needed for bumper-less shaft extraction compared to standard skin level 
removal of collapsible bumper graded: similar harder, lighter, much lighter, 
negligible (comparable to endoscope withdraw from esophagus. 
17. Patient discomfort during the procedure. 
  
Bumper flanges expulsion 
18. Sensation in communicating patients. 

 
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19. Complete expulsion fluoroscopically proven by abdominal X-Ray imaging (in 
case particle/s from the bumper can be seen in the imaging a further follow visit 
will be scheduled only in case of symptoms related event/s, as per physician 
discretion) 
 
8.4 SAMPLE SIZE JUSTIFICATION 
15 adult patients, males or females, scheduled for PEG (Newly PEG insertion and PEG 
replacement involving endoscopy procedure). There will be minimum of 10 Newly PEG 
inserted patients enrolled to the study from the overall sample size. 
Due to the small sample size and study early stage, no formal sample size calculation 
was done for this study. 
 
9 SELECTION AND WITHDRAWAL OF SUBJECTS 
 
9.1 STUDY POPULATION AND JUSTIFICATION 
Adult patients, males or females suffering from dysphagia who are scheduled for PEG 
(Newly PEG insertion and PEG replacement involving endoscopy procedure) with 
protocol local anesthetic. There will be minimum of 10 Newly PEG inserted patients 
enrolled to the study from the overall sample size. 
The enrollment of patients to be studied in the clinical trial will respect a gender 
criterion in order to involve a similar number of male and female patients in the study 
and highlight any specific differences observed that might refer to biological 
characteristics and social/cultural factors.  
 
9.2 ELIGIBILITY CRITERIA 
 
 
9.2.1 Inclusion Criteria  
1. Male or female patient 18 up to 90 years. 
2. Consecutive adult patients suffering from oropharyngeal dysphagia 
impairing or anticipated to impair the patients' nutritional status with 
need for enteral feeding (PEG). 
3. Ability to give informed consent for the study by patient or legal 
guardian. 

 
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4. Willingness to undergo 4 follow up visits 1, 3 and 4 months following 
PEG insertion/replacement, as well as unscheduled sick visits. 
 
9.2.2 Exclusion Criteria  
1. 
Pregnancy (all women of child-bearing age would be questioned and told 
by the consenting physician regarding that criteria). 
2. 
All current practice PEG contraindication 
3. 
Acute gastrointestinal bleeding 
4. 
Extreme obesity patients (BMI>40) 
5. 
Emergency endoscopy 
6. 
Infectious disease local or systemic (e.g.- sepsis, pancreatitis) 
7. 
Known esophageal pathology  (e.g.- stenosis, eosinophilic esophagitis, 
varices,  achalasia, reflux) 
8. 
In case of PEG replacement: lack of a well healed gastrostomy or 
Infection around the insertion site. 
9. 
Known gastric pathology that may prevent safe device insertion, 
feeding, removal and Bumper flanges expulsion according to the 
investigator discretion.  
10. 
Any history of bowel obstruction, pseudo-obstruction. 
11. 
Crohn's disease 
12. 
Severe GERD, recurrent vomiting  
13. 
Inability to tolerate sedated upper endoscopy due to cardio-pulmonary 
instability or other contraindication to endoscopy 
14. 
Current enrollment in an investigational drug or device study or 
participation in such a study within 30 days of entry into this study. 
 
9.2.3 Reasons 
for 
Withdrawal 
or 
Termination 
(Early 
Discontinuation): 
 
Patients will be removed from study when any of the criteria listed below applies.  The 
reason/s for study removal and the date in which the patient was removed will be 
documented in the Case Report Form (CRF):   
9.2.3.1 
Patients not complying with the protocol requirements. 
9.2.3.2 
AE resulting in discontinuation of the study. 
9.2.3.3 
Patient decides to withdraw from the study. 
9.2.3.4 
IRB request to discontinue the study. 

 
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9.2.3.5 
Lack of adherence of stomach to abdominal wall. 
9.2.3.6 
Inability to complete Fidmi device gastrostomy placement 
 
9.2.4 Handling of Participant Withdrawals or termination 
The participation in the study, as in any clinical study, is voluntary and participants are allowed 
to withdraw from the study at any time. 
Participants who leave the study prematurely will be replaced. A patient discontinuing the 
study before Fidmi PEG placement can be replaced, at the discretion of the investigator, by 
another consenting patient. The discontinuing patient will be followed for safety. 
We anticipate from previous reports (9) that about 20% will not complete the 4 months study 
due to death and addition of 20% will withdraw from the study due the above listed reasons.  
Each case of premature withdrawal will be properly recorded. As deemed necessary.  
 
9.3 9.3 SUBJECT ENROLLMENT 
 
9.3.1 SCREENING  
The study will be conducted both in the Gastrology Institute at Shaare Zedek Medical 
Center, Jerusalem, Israel and in the Gastrology Institute at Hadassah Medical Center, 
Jerusalem, Israel. Prior to any study-related screening procedure, delegated study 
team members (investigators and nurses) will approach potentially eligible adults 
subjects suffering from oropharyngeal dysphagia impairing or anticipated to impair 
the patients' nutritional status, who are waiting to be scheduled for PEG insertion or 
replacement, involving endoscopy procedure.  Those who may be eligible will be 
offered the choice of undergoing screening to potentially enroll in the study or 
receiving free treatment for their current illness without participating in the study. 
Subjects who do not meet inclusion criteria or who are for any other reason 
determined to be too ill for inclusion in the study, or who decline to participate in the 
study, will be considered and recorded as "screen failure" and receive standard and 
appropriate treatment. 

 
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9.3.2 CONSENTING 
 
Consenting will be performed at the Gastrology Institute at Shaare Zedek Medical 
Center.  In case of 'special population consenting' (demented patients) a designated 
consenting form (3A) as deemed by the Israeli MOH (HANOHAL) will be signed by the 
patient guardian and a copy of the signed Apotropos authorization documents would 
be collected and documented in the patient binder .  Any use of study samples that is 
outside the scope of the objectives of this protocol will be submitted for prior review 
and approval by the appropriate IRBs. The informed consent document will be signed 
and dated for screening and enrollment and each subject consenting will be 
documented in the subject medical binder. The patient will be given a copy of the 
consent form together with the study doctor's letter at the time of enrollment.  The 
clinician will ask the patient about his plans and his willingness to attend all scheduled 
and unscheduled follow-up visits. 
 
9.4 
SUBJECT IDENTIFICATION 
 
Patients will be identified by a serial number and will be numbered according to the 
site number (first digit) and their recruitment (2nd and 3rd digits): e.g. 101, 203 etc.  
 
 
9.5 
SCREENING FAILURE 
Patients who have not fulfilled all the inclusion criteria, or have fulfilled one of the 
exclusion criteria will not be included in this study.  Patient who have screen failure 
will be replaced. 
9.6 
SUBJECT ACCOUNTABILITY 
 
Once subject is screened and enrolled into the study the following study logs will be 
documented : 

 
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Enrollment Log - Indicates all eligible subjects who signed the informed consent and were 
enrolled to the study. This log includes for each subject his/her subject identification number 
and the dates of signing the informed consent and of enrollment. 
Subject Consenting Log – documents all subjects enrolled and details their ICF consenting 
details: date, ICF version, consenting investigator, re-consenting if required etc.  
Patient Identification Log - Correlates the name and details of every subject with the relevant 
subject identification number. This log should be kept only at the investigational site. 
Subject Visit log – list all planned visits (1-7) for each enrolled subject. This log can be filled 
further on the study conduct. 
 
10 TRIAL PROCEDURES 
For study Schedule of Assessment, refer to  
 

 
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Table 3 - Visit procedure chart. No procedure or evaluation will be done prior to 
obtaining study consent.  
After informed consent is obtained, a case record form (CRF) including all listed below 
will be recorded. Eligible patients will be enrolled into the study and be treated 
according to standard treatment protocols with PEG device insertion procedure with 
protocol local anesthetic. 
 
10.1 STUDY SPECIFIC PROCEDURES 
 
10.1.1 PATIENT ENROLLMENT TO DISCHARGE 
 
Visit 1: Screening and Enrollment, as part of PEG pre-operative visit (can be 
performed up until 2 weeks before insertion procedure - visit 2) 
Following signing of informed consent, patients scheduled and amenable for PEG 
insertion/replacement, will be screened for study enrollment by assessment of 
inclusion and exclusion criteria.  The following assessments will be performed:  
▪ Demographics (gender, age, race, ethnicity). 
▪ Medical history (principal diagnosis requiring enteral nutrition, or 
hospitalization in the last 12 months). 
▪ Vital signs 
▪ Current medications. 
▪ Physical examination. 
 
Eligible patients will be enrolled into the study and be treated according to standard 
treatment protocols with PEG insertion/replacement.   
The procedure for the PEG insertion/removal (Visit 2, see below) may be performed 
at the day of enrollment  
 
Visit 2: Insertion/replacement of Fidmi device in the Endoscopy suite  
 
If the procedure is taken on a different day than the inclusion day then the following 
assessments will be completed prior the procedure conducted: 
  
a) Eligibility criteria 

 
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b) Physical examination  
c) Vital signs 
All patients will be operated by study delegated Gastroenterologist by the same 
method (see Investigator Brochure). Antibiotics will be administrated to patients on 
trial according to the investigator discretion.  
The insertion procedure is performed by the investigator physician in a dimmed 
lighted room while the device is placed on a bedside tray under a protocol of local 
anesthetic. 
Fidmi device method of insertion is detailed and illustrated in the Investigator 
Brochure. 
An anonymous endoscopy recording of the procedure will be obtained for each 
patient. 
 
Patients’ charts will be reviewed and the following assessments will be completed 
following the procedure:  
d) Illuminated clear photos of the insertion/replacement site taken:  
o Frontal to the insertion site/ external bumper 
o Perpendicular (from the profile) to the insertion site/ external bumper 
o In close perspective if outstanding issues (medical or technical) are 
observed 
e) An anonymous endoscopy recording of the procedure 
f) PEG Physician usability Form 
Study PEG insertion Form: 
insertion  needed number of needle Re-puncture (sheath kink, loss of 
visualization), PEG insertion characteristics and duration, PEG placement 
location, Stoma Insertion/Removal site, Residual Tube above skin evaluation, 
heart rate at the end of the operation, time to resume typical enteric diet, 
amount and type of analgesia consumed, postoperative bleeding, use of anti-
bleeding agents (such as tranexemic acid (hexakapron)). 

 
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Endoscopist feedback Form: Endoscopist 10-point Visual Analogue Scale for 
placement/removal procedure difficulty.   
g) Study Patient Discharge form. 
 
A study qualified personnel will instruct the patient before discharge with specific 
home instructions for use (IFU), maintenance, and instructions on how to periodically 
replace the Fidmi Disposable Feeding Tube when needed (see appendix in the IB). 
Together with the IFU leaflet the patient would be provided with his home Fidmi 
Disposable Feeding Tube pack. Instructions about the patient diet and medication 
should be given separately to the study. 
 The patient will be asked for his most convenient day for the Visit 3 follow up (see 
below) – this day will be recorded by the study nurse at the Patient Visits Log. 
 
10.1.2 PATIENT FOLLOW UPS AND PEG REMOVAL 
Patients will be monitored for follow-up after 2, 30, 60 and 90 and 120 days following 
their PEG insertion/replacement procedure and will be evaluated by the study nurse 
for their medical conditions. PEG device removal will be conducted 3 months following 
its placement.  
Visit 3: Follow up 2 days (+/- 1 day) following procedure (sub-investigator visit in 
patient facility) 
In compliance with the Centric Patient Approach, study delegated sub-investigator will 
visit the patient facility at the specific day scheduled together. The patient will be 
asked to report his nutritional status (malnutrition defined as a body mass index [BMI] 
<19 kg/m2) and any stomal complication (wound infection, peristomal leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external bumper) – all 
will be investigated by the study sub-investigator using Visit 3 safety Follow Up Form. 

 
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In addition patient will be asked regarding his postoperative morbidity, any other 
Adverse Events and Concomitant medications. 
Illuminated clear photos of the insertion site will be taken:  
o Frontal to the insertion site/ external bumper 
o Perpendicular (from the profile) to the insertion site/ external bumper 
o In close perspective if outstanding issues (medical or technical) are 
observed 
The study sub-investigator will also investigate tube performance: accidental 
dislodgement, buried bumper, gastric outlet obstruction, tube leakage, Residual Tube 
above skin evaluation, number of scheduled tube replacement, method of feeding 
(bolus, continues gravity, mechanical pump etc.), Scale 1-10 – ease of connecting the 
extension tube, ease of feeding, any replacements of disposable tubes other than 
scheduled (and reason) using Visit 3 Tube Utilization Form. 
The following assessments will be conducted: 
a) Physical examination  
b) Vital signs 
   
The patient will be asked for his most convenient day for his 30 days follow-up (Visit 4 
follow up, see below) – this day will be recorded by the study nurse at the Patient 
Visits Log. 
Visit 4: Follow up after 1 month +/- 10 days (sub-investigator visit in patient facility) 
In compliance with the Centric Patient Approach, delegated study sub-investigator will 
visit the patient facility at the specific day scheduled together. The patient will be 
asked to report his nutritional status (malnutrition defined as a body mass index [BMI] 
<19 kg/m2) and any stomal complication (wound infection, peristomal leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external bumper) – all 
will be investigated by the study sub-investigator using Visit 4 safety Follow Up Form. 

 
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In addition patient will be asked regarding his postoperative morbidity, any other 
Adverse Events and Concomitant medications. 
Illuminated clear photos of the insertion site will be taken:  
o Frontal to the insertion site/ external bumper 
o Perpendicular (from the profile) to the insertion site/ external bumper 
o In close perspective if outstanding issues (medical or technical) are 
observed 
The study sub-investigator will also investigate tube performance: accidental 
dislodgement, buried bumper, gastric outlet obstruction, tube leakage, Residual Tube 
above skin evaluation, number of scheduled tube replacement, method of feeding 
(bolus, continues gravity, mechanical pump etc.), Scale 1-10 – ease of connecting the 
extension tube, ease of feeding, any replacements of disposable tubes other than 
scheduled (and reason) using Visit 4 Tube Utilization Form. 
The following assessments will be conducted:  
a) Physical examination  
b) Vital signs 
 
The patient will be asked for his most convenient day for the PEG removal hospital 
visit (Visit 6 follow up, see below) – this day will be recorded by the study nurse at the 
Patient Visits Log. 
Visit 5: Follow up after 2 months +/- 10 days (phone call follow up) 
In compliance with the Centric Patient Approach, delegated study member will call 
the patient facility at the specific day scheduled together. The patient will be asked to 
report his nutritional status (malnutrition defined as a body mass index [BMI] <19 
kg/m2) and any stomal complication (wound infection, peristomal leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external bumper) – all 
will be investigated by the study nurse using Visit 5 safety Follow Up Form. In addition 

 
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patient will be asked regarding his postoperative morbidity, any other Adverse Events 
and Concomitant medications. 
The study personnel will also investigate tube performance: accidental dislodgement, 
buried bumper, gastric outlet obstruction, tube leakage, Residual Tube above skin 
evaluation, number of scheduled tube replacement, method of feeding (bolus, 
continues gravity, mechanical pump etc.), Scale 1-10 – ease of connecting the 
extension tube, ease of feeding, any replacements of disposable tubes other than 
scheduled (and reason) using Visit 5 Tube Utilization Form. 
The patient will also be reminded for already scheduled day for the PEG removal 
hospital visit (Visit 6 follow up, see Patient Visits Log). 
  
Visit 6: Follow up after 3 months +/- 10 and Fidmi device removal/replacement by 
balloon gastrostomy.  
 
Prior to the procedure the patient will be asked to report his nutritional status 
(malnutrition defined as a body mass index [BMI] <19 kg/m2) and any stomal 
complication (wound infection, peristomal leakage, hypergranulation, pressure ulcer, 
any skin lesion adjacent to external bumper) – all will be investigated by the study 
nurse using Visit 6 safety Follow Up Form. In addition patient will be asked regarding 
his postoperative morbidity, any other Adverse Events, Concomitant medications. 
Illuminated clear photos of the insertion site will be taken:  
o Frontal to the insertion site/ external bumper 
o Perpendicular (from the profile) to the insertion site/ external bumper 
o In close perspective if outstanding issues (medical or technical) are 
observed 
Study nurse will also investigate tube performance: accidental dislodgement, buried 
bumper, gastric outlet obstruction, tube leakage, Residual Tube above skin evaluation, 
number of scheduled tube replacement, method of feeding (bolus, continues gravity, 
mechanical pump etc.), Scale 1-10 – ease of connecting the extension tube, ease of 
feeding, any replacements of disposable tubes other than scheduled (and reason) 
using Visit 6 Tube Utilization Form   

 
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The following assessments will be conducted prior to device removal/ replacement by 
balloon gastrostomy:  
a) Physical examination  
b) Vital signs 
*An endoscopic examination is not required but may be performed on a need base, 
and following the investigator discretion. 
 
In case a Gastrostom replacement is required, the study investigator will advise the 
patient from various types of technologically equivalent or similar devices including 
'low profile' types. The replacement procedure will be performed routinely as 
specified in the Instruction for Use.  
The following assessments will be conducted following the device removal/ 
replacement by balloon gastrostomy:  
c) PEG Physician usability Form 
Study PEG removal Form: 
Procedure duration, heart rate at the end of the operation, amount and type 
of analgesia consumed, postoperative bleeding, use of anti-bleeding agents 
(such as tranexemic acid (hexakapron)). 
Endoscopist feedback Form: Endoscopist 10-point Visual Analogue Scale for 
removal procedure difficulty.   
d) Patient PEG removal/ replacement Feedback Form 
e) Study Patient Discharge form. 
 
The discharging study investigator will instruct the patient (or his care giver) to 
immediately call the site in case of: vomiting, swollen belly, repeated abdominal aches 
and general deterioration (for demented patients).  In case there is a suspicious of GI 
perforation or hemorrhage bowel obstruction the study investigator will schedule an 
un-scheduled visit. 

 
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The patient will be asked for his most convenient day for the termination visit (Visit 7 
study termination, see below) – this day will be recorded by the study nurse at the 
Patient Visits Log. 
 
Visit 7: Follow up after 4 months +/- 10, X-ray and termination visit 
In compliance with the Centric Patient Approach, a home X-ray examination will be 
offered to the patient and his family. If chosen, a certified technician (Medix at Home, 
FDA and MOH approved) will visit the patient facility at the specific day scheduled 
together, in order to conveniently perform abdominal X-ray examination (required to 
verify Bumper flanges expulsion). A copy of the imaging will be provided to delegated 
sub-investigator for evaluation.  
Following the X-ray examination, a delegated study member will call the patient 
facility to verify no technical issues occurred. The patient will be asked to report his 
nutritional status (malnutrition defined as a body mass index [BMI] <19 kg/m2) and 
any stomal complication (wound infection, peristomal leakage, hypergranulation, 
pressure ulcer, any skin lesion adjacent to external bumper) – all will be investigated 
by the study nurse using Visit 7 safety Follow Up Form. In addition, patient will be 
asked regarding his postoperative morbidity, any other Adverse Events and 
Concomitant medications. 
Alternatively, the patient will be admitted to the Gastrology Institute at Shaare Zedek 
Medical Center, Jerusalem an hour before the planned X-ray examination scheduled 
time accompanied by the study nurse. Prior to the examination he will be asked to 
report his nutritional status (malnutrition defined as a body mass index [BMI] <19 
kg/m2 and any stomal complication (wound infection, peristomal leakage, 
hypergranulation, pressure ulcer, any skin lesion adjacent to external bumper) – all 
will be investigated by the study nurse using Visit 7 safety Follow Up Form. In addition, 

 
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patient will be asked regarding his postoperative morbidity, any other Adverse Events, 
Concomitant medications. 
The following forms will be completed: 
a) Post PEG removal imaging Form 
b) Termination visit 
 
*An endoscopic examination is not required but may be performed on a need base, and 
following the investigator discretion. 
 
Un-scheduled visit:  
In case particle/s from the bumper can be seen in the imaging the discharging study 
investigator will instruct the patient (or his care giver) to immediately refer his caring doctor 
in case of: vomiting, swollen belly, repeated abdominal aches and general deterioration (for 
demented patients).  The patient must call the study nurse to schedule an un-scheduled visit 
only under his caring doctor discretion of: GI perforation or hemorrhage or bowel obstruction. 
In such case Un-scheduled visit form will be recorded. In that kind of visit the patient will be 
clinically managed by the study team in the Institute of Gastroenterology and Liver Diseases 
until. An additional X-ray imaging will be performed to illustrate and determine the 
localization of the retained particles. In case of colon localization the PI will consider removing 
those particles by colonoscopy procedure. 
 
 
 

 
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Table 3 - Visit procedure chart 
  
Enrollment 
and device 
placement 
Follow Up Period 
Procedure 
Screening & 
Enrollment 
Fidmi device 
insertion 
Sub-I visit in 
patient facility 
Sub-I visit in 
patient facility 
Follow up call 
with the patient 
Fidmi device 
removal 
X-ray and 
termination visit 
Visits 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
Time Schedule (Days) 
-7 
0 
2 
30 
60 
90 
120 
Time Window (+/- Days) 
7 
1 
10 
10 
10 
14 
Informed consent 
X 
 
 
 
 
 
 
Demographics+ Med. history 
X 
 
 
 
 
 
 
Concomitant medications 
X 
x ------------------------------------------------------------ 
Physical exam 
X 
x 
x 
x 
 
x 
 
Vital signs  
X 
x 
x 
x 
 
x 
 
Adverse event evaluation 
 
x ------------------------------------------------------------- 
Endoscopy recording 
 
x 
 
 
 
 
 
Photos of the insertion site 
 
x 
x 
x 
 
x 
 
PEG usability Form (physician) 
 
x 
 
 
 
x 
 
Patient Discharge form 
 
x 
 
 
 
x 
 
Safety Follow Up Form 
 
 
X 
X 
X 
x 
x 
Tube Utilization Form  
(patient/care giver) 
 
 
X 
X 
X 
x 
 
Patient feedback Form 
 
 
 
 
 
x 
 
Patient Bumper flanges 
expulsion Form 
 
 
 
 
 
 
x 
X-ray imaging (home/clinic) 
 
 
 
 
 
 
x 
Post PEG removal imaging Form 
 
 
 
 
 
 
x 
Termination Visit 
 
 
 
 
 
 
x 
Subject Visit log 
 
X 
X 
X 
X 
x 
 
Un-scheduled visit Form (if 
needed) 
 
 
 
 
 
 
 
 
 
 
 

 
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10.2 
SCALES AND EVALUATIONS 
Physical examination 
A standard physical examination will be conducted on participating patients in all study 
visits. These will be conducted by the investigator or by any other authorized member of the 
study team.   
Physical examination will include weight measurements, lungs, cardiovascular system, 
abdomen, musculoskeletal system, skin, lymph nodes, and central nervous system and, 
where appropriate, other body systems per discretion of investigator (see CRF).  
Vital signs 
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, and blood oxygen 
saturation) will be collected at all study visits.  
Illuminated photos of the insertion site 
All photos taken must be performed exactly like the previous visits- same shape and distance 
 *If the patient has any lesion such as an ischemic area, gangrene, ulcer, rush, edema etc. –
take at least one close photograph demonstrating the lesion. Take a new photo of every new 
lesion that appears through the visits. 
 
11 SAFETY ASSESSMENT 
 
11.1 
Anticipated Adverse Events 
 
Placement complication: excessive stoma wound bleeding, over tightened external 
bumper, gastric and/or esophageal laceration, aspiration, device unintended 
disassembly, need for more than one needle puncture 
 
Post placement complication; [Time Frame: 1week-4 months]: Fever, gastric 
distention, 
infection, 
blockage/ 
occlusion, 
tissue 
necrosis, 
migration, 
erosion/embedding into the gastric wall (“Buried Bumper Syndrome”), aspiration, 
bleeding, fistula, GE reflux, pain, perforation, ulceration, pressure sores, skin lesion 
(tissue granulation) adjacent to external bumper, dumping syndrome, tube clogging, 
malposition, leakage, kinking, inadvertent removal, small bowel obstruction, and 
granulation tissue. 
 
Post removal complication: Bowel obstruction, Bowel peroration, GI bleeding, painful 
defecation. 
 
Death after PEG procedure 

 
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The average survival time of patients undergoing PEG insertion is 720 days (9). At Day-30 
following PEG insertion, 6.5% - 19% of the patients dies from complications Predictive factors 
of increased 30-day mortality were higher age, lower body mass index (BMI), and the presence 
of diabetes mellitus. (10) 
97% of death occurred following PEG insertion (30 days' time window) patients have 
coexistent neurologic disease. Main death causes are: cardiovascular disease, respiratory 
disease and central nervous system disease. (11). Most patients demonstrate multiple co-
morbidities and a poor functional baseline level pre-procedure.  
Significant higher mortality rates (7 times higher) were observed in PEG inserted patients that 
were hospitalized during that time (first 30 days) compared to patients from nursing homes 
(12) 
11.2 
Precaution to Minimize Risk 
 
The abovementioned risks will be minimized by having trained and qualified clinicians 
perform the procedure. Clinicians will be available for evaluation if there is any 
untoward effect. 
In addition, sterile unused needles and lancets will always be used and pressure will 
be held at the insertion site after placing the PEG device. Further mitigations: 
• Antibiotics as prescribed by the investigator 
• Study nurse will provide the patient with Home instruction including 
emergency call (24 hours). 
• Tactile Fidmi device placement/replacement and removal performed only by 
trained and qualified physicians. 
• X-ray imaging to ensure bumper flanges expulsion 
• Readiness and patient guidance for "un-scheduled visits"  
 
11.3 
ADVERSE EVENTS REPORTING 
 
 

 
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Adverse Events (AE) will be done according to National Cancer Institute (NCI) 
Terminology Criteria for Adverse Events v4.0 common terminology criteria for AE 
(CTCAE). See link for CTCAE v4.0 - (13).  
AE will be collected throughout the study and recorded on the CRF. Pre-existing 
conditions will not be considered AEs only if they worsen beyond what would be 
expected. In all cases, the etiology should, as much as possible, be identified, 
recorded, and the Sponsor notified. 
11.3.1 ADVERSE EVENT SEVERITTY 
The severity of the AE will be evaluated by the Common Terminology Criteria for 
Adverse Events (CTCAE), version 4.0, for toxicity and adverse event reporting.  A copy 
of the CTC Version 4.0 should be accessed from the CTEP site (13)- containing all NCI 
Common Terminology Criteria for Adverse Events (CTCAE) v.4 data files and related 
documents. All treatment personnel should have access to a copy of the CTC version 
4.0.  
Each CTCAE term is a representation of a specific event and corresponds to a single 
MedDRA Lowest Level Term (LLT). Grade relates to severity for the purposes of 
regulatory reporting and is defined as follows:  
0. No AE (or within normal limits).  
1. Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated.  
2. Moderate; minimal, local, or noninvasive intervention (e.g., packing, 
cautery) indicated; limiting age-appropriate instrumental activities of daily 
living (ADL).  
3. Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self-care ADL.  
4. Life-threatening consequences; urgent intervention indicated.  
5. Death related to AE. 
 
The investigator shall appoint a safety monitor who will assess the relationship of 
the observed symptoms to the investigational treatment.   AEs will be collected 

 
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from subject enrollment through follow-up period.  In all cases, the etiology 
should, as much as possible, be identified and the Sponsor notified. 
AE will be assessed by the investigator for severity, causality and outcome. 
Figure  
4  - AE definition (ADE- Adverse drug event, SADE-serious adverse device event) 
 
 
11.3.2 ADVERSE EVENT OUTCOME 
The outcome of an AE will be assessed as: 
• Recovered/resolved - recovered or resolved without medical sequelae. “Stop 
date” of the event should be the date the event is no longer present or 
stabilizes. If there are lingering effects after a patient is discharged then the 
event will not resolve until all symptoms have ceased or stabilized. 

 
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• Not recovered/not resolved - for an ongoing AE - for AEs that did not cause 
the death and were not resolved prior to the death, the outcomes for these 
events will be entered as “Ongoing.” 
• Recovering/resolving - in the process of writing of the report 
• Recovered with sequelae/resolved with sequelae- the nature of the sequelae 
will be reported 
Fatal (SAEs only) - the date of dead will be reported, the autopsy report will be 
given, if one will be done. 
 
11.3.3 SERIOUS ADVERSE EVENT  
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 
• Results in death, 
• Is life-threatening. Note: The term “life-threatening” in the definition of 
“serious” refers to an event in which the patient was at risk of death at the 
time of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe. 
• Requires inpatient hospitalization or prolongation of existing hospitalization, 
• Required Intervention to Prevent Permanent Impairment or Damage (Devices) 
• Medical or surgical intervention was necessary to preclude permanent 
impairment of a body function, or prevent permanent damage to a body 
structure, either situation suspected to be due to the use of a medical product. 
• Results in persistent or significant disability/incapacity, or 
• Is a congenital anomaly/birth defect (not applicable to this study). 

 
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Medical and scientific judgment will be exercised in deciding whether expedited 
reporting is appropriate in other situations, such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but may 
jeopardize the patient or may require intervention to prevent one of the other 
outcomes listed in the definition above. These should also usually be considered 
serious. 
11.3.4 REPORTING SERIOUS ADVERSE EVENT 
Medical judgment will be exercised in deciding whether an adverse event/reaction is 
serious in other situations. Important adverse events/ reactions that are not 
immediately life-threatening or do not result in death or hospitalization, but may 
jeopardize the patient or may require intervention to prevent one of the other 
outcomes listed in the definition above, may also be considered serious . 
In order to satisfy regulatory requirements, any Serious and Unanticipated Events, 
whether investigational product deemed related or not, must be reported to the 
Sponsor/ Designated CRO as soon as possible after the investigator or coordinator has 
become aware of its occurrence. The SAE form completion and reporting must not be 
delayed even if not all of the information is available at the time of the initial contact. 
The Serious Adverse Event (SAE) form should be submitted within 24 hours of 
becoming aware of the event to the Sponsor/ Designated CRO . 
Additional information (follow-up) regarding any SAE unavailable at the initial 
reporting should be forwarded by the site within 24 hours of the information 
becoming available to the Sponsor or designee . 
Serious adverse events should be reported by the site to their EC/IRB as dictated by 
their hospital policies and procedures using Matarot clinical study designated 
software. 

 
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Subjects who have had an SAE during the treatment period may be followed clinically 
until all parameters (including laboratory) have either returned to normal or have 
stabilized or are otherwise explained. The investigator is responsible for the ongoing 
safety assessment of the investigational products. The Sponsor shall inform all the 
parties involved in the conduct and approval of the trial, i.e. the Investigators, IRBs 
and the Ministry of Health, of findings that may affect the safety of trial participants, 
or findings which have implications on the method of trial conduct, or findings that 
may affect the decision of the parties that approved the trial. The investigator is 
responsible for the ongoing safety assessment of the investigational products. The 
Sponsor shall inform all the parties involved in the conduct and approval of the trial, 
i.e. the Investigators, IRBs and the Ministry of Health, of findings that may affect the 
safety of trial participants, or findings which have implications on the method of trial 
conduct, or findings that may affect the decision of the parties that approved the trial. 
 
11.3.5 SERIOUS ADVERSE DEVICE EVENT 
Any serious adverse event somehow related to treatment with the investigational 
product. 
11.3.6 POST-TRIAL EVALUATIONS  
Patients who have moderate or severe on-going adverse events at the completion of 
the study will be advised to consult their personal physician if the event is not 
considered to be related to the index hospitalization. An un-scheduled visit will be 
arranged to manage the problem and to determine the severity and duration of the 
event, if it is considered to be related to the investigational device. If appropriate, 
specialist review within the MOH will be arranged.  
 

 
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12 STATISTICAL ANALYSIS 
 
This study is an early feasibility research to primarily test the safety and usability of 
the investigated device. 
All data obtained in this study and documented in the Case Report Forms will be listed 
and tabulated with descriptive group statistics (mean, standard deviation, minimum, 
maximum, number of valid cases), as appropriate.  
For continuous variables such as age, body weight, vital signs, etc. descriptive group 
statistics (n, mean, standard deviation, minimum, maximum and number of valid 
cases), will be used as appropriate. For categorical discrete variables data, such as sex, 
number of Adverse Events (occurrence, severity, relationship with), etc., frequency 
and percentage will be computed.  
Incidences of AEs will be presented by MedDRA system class, intensity, seriousness, 
and relation to study investigational product.  
 

 
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13 INVESTIGATION ADMINISTRATION 
 
 
13.1 
IRB/EC APPROVAL  
This study including protocol, the informed consent document, relevant supporting 
information and all types of patient recruitment information will be presented for 
approval to the Helsinki Committee of the Shaare Zedek Hebrew University Medical 
Center, Jerusalem prior to any study initiation. An update of the addition of medical 
site will be notofied to the Israeli ministry of health (MOH) 
The study will be conducted according to the rules and regulations of the state of 
Israel, those of the Shaare Zedek Hebrew University Medical Center, and will follow 
the IRB approved protocol. Written informed consent would be obtained from all 
patients and/or their guardian before enrollment in the study and a copy of the signed 
Apotropos authorization documents would be collected and documented in the 
patient binder. The study will be monitored annually by the IRB. The trial will be 
registered with http://www.clinicaltrials.gov and the Israeli MOH clinical trials 
registry. 
 
This trial will be conducted in accordance with the Declaration of Helsinki (see 10.9) 
as agreed by the World Medical Association General Assembly (Seoul 2008), ICH Good 
Clinical Practice and local regulatory requirements. 
The investigator will be responsible for keeping their local IRB informed of the 
progress with study renewal at least once a year. The investigator will also keep the 
local IRB informed of any significant adverse events, per local institutional guidelines. 
Adverse event reporting guidelines can be found in Section 11.3, Reporting Adverse 
Events. 
13.2 
DATA MONITORING AND QUALITY CONTROL 
 
The investigator, through an appointed Clinical Research Associate (CRA), will be 
responsible for implementing and maintaining quality assurance and quality control 
systems with written SOPs to ensure that trials are conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirement(s) . 

 
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The investigator will be responsible for ensuring direct access to all trial related sites, 
source data/documents, and reports for the purpose of monitoring and auditing by 
the hospital, and inspection by Israeli regulatory authorities . 
Quality control should be applied to each stage of data handling to ensure that all data 
are reliable and have been processed correctly. 
The study CRA will verify that (a) The rights and well-being of human patients are 
protected, (b) The reported trial data are accurate, complete, and verifiable from 
source documents and (c) The conduct of the trial is in compliance with the currently 
approved protocol/amendment(s), with GCP, and with the applicable regulatory 
requirement(s). The full responsibilities of the trial monitor appear in full in the ICH-
GCP. 
The monitor(s) should follow Fidmi (or their CRO representative) written for 
monitoring the specific trial. 
The monitor will submit a written report after each trial-site visit or trial-related 
communication. A report should include the date, site, name of the monitor, and 
name of the investigator or other individual(s) contacted. A report should include a 
summary of what the monitor reviewed and the monitor's statements concerning the 
significant findings/facts, deviations and deficiencies, conclusions, actions taken or to 
be taken and/or actions recommended to secure compliance.  
To ensure compliance of this investigator initiated trial with current national 
regulations and the ICH guidelines, data generated by this study will be available for 
inspection upon request by representatives of the local health authorities- IRB or the 
national authorities -  MOH, or any entity providing support for this trial. Routine 
monitoring or audit activities for this study will be conducted by authorized 
representatives. The general scope of such visits would be to inspect study data 
(regulatory requirements), source documentation and CRF completion in accordance 
with current Good Clinical Practices (GCP), the ICH guidelines and the respective local 
and national government regulations and guidelines.  
The IRB will supervise the clinical trial and shall receive periodic reports from the 
investigators. The IRB shall receive an interim report on safety on an annually base. 
The committee shall also receive regular reports of adverse events occurring during 
the trial and shall discuss these events with the investigator. 
 

 
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13.3 
SUBJECT CONFIDENTIALITY 
 
The original data collection forms will be stored in secured cabinets at the originating 
institution.  Institutional policy and guidance on requirements for managing clinical 
research data will be followed, including the appropriate levels of safeguard to ensure 
the confidentiality, integrity and availability of clinical research data. 
The patients' confidentiality will be maintained and will only be accessible to study 
staff and to CRA designated by the investigator. The only non-hospital personnel 
notified as to participation of the patient in the study will be the family physician.  
Patient will be de-identified using a systematic number (see above). 
 
13.4 
PROTOCOL MODIFICATIONS  
13.4.1 Protocol Deviations  
The instructions and procedures specified in this protocol require diligent attention to 
their execution.  No alterations or changes to this protocol will be permitted.  
However, should there be question or consideration of deviation from the protocol, 
clarification must be sought from the sponsor's clinical monitor.  Any subject treated 
in a manner that deviates from the protocol, or who is admitted into the study but is 
not qualified according to the protocol, may be ineligible for analysis and thereby 
compromises the study.  The investigator and research team must comply with all 
applicable, state and local laws. 
All Protocol Deviations would be reported to the local IRB via MATAROT specific form 
signed by the PI together with occurrence date, detailed deviation and justification 
cause. Accordingly all protocol deviations would be documented in a specific study 
Protocol Deviation log. 
 
13.4.2 Protocol Amendments 
 
The protocol cannot be amended by the investigators or study personnel without first 
obtaining IRB review and the concurrence of the investigator and the sponsor.  
Medically significant amendments to the protocol (e.g., affect the rights, safety, or 
welfare of the human subjects involved in the investigation, the scientific soundness 

 
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of the investigational plan, the validity of data or information resulting from the 
completion of an approved protocol, or the relationship of likely subject risk to benefit 
relied upon to approve a protocol or if they are otherwise significant inclusion of new 
categories of subjects, etc.) may not be instituted prior to regulatory approval by 
relevant IRB and MOH. 
 
13.5 
STUDY DOCUMENTATION 
 
13.5.1 Patient File  
The investigator will ensure the completeness of patient files, which will include the 
following documents:  
▪ Signed ICF  
▪ Letter to family physician 
▪ Completed and signed CRF 
▪ 
An anonymous endoscopy recording of the procedure 
▪ 
Illuminated clear photos of the insertion/replacement site 
▪ 
Study Patient Discharge form. 
▪ Source documents (with the patient’s identifying information crossed-out) 
 
13.5.2 Source Documents  
Source documents are original records in which raw data are first recorded.  These 
may be office/clinic/hospital records, charts, diaries, x-rays, and laboratory results, 
printouts, pharmacy records, care records, completed scales for each study 
participant.  Source documents should be kept in a secure and limited access area.  All 
source documents must be accurate, clear, unambiguous, permanent and capable of 
being audited. They should be made using a permanent form of recording (ink, typing, 
printing, optical disc etc).  They should not be obscured by correcting fluid or have 
temporary attachments (such as removable self-stick notes).  Source documents that 

 
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are computer generated and stored electronically must be printed (for review by the 
study monitor), signed and dated by the investigator . 
Source documents for this trial will include the following:  
▪ Informed Consent Forms. 
▪ Apotropos signed authorization documents (when applicable) 
▪ Completed CRF. 
▪ Patient medical file including Surgery and Discharge Reports 
▪ Physical examination results. 
▪ X-Ray imaging and evaluation 
Source data for subjects should indicate participation in clinical protocol number and 
title, treatment number, evidence that inclusion/exclusion criteria have been met. 
13.5.3 CRFs  
Study data will be collected using paper case report forms (CRF). The PI will be 
responsible for the timeliness, completeness, and accuracy of the information on the 
CRF.  All entries must be legibly recorded in black or blue ink.  The entry to be corrected 
is to be crossed out with a single line so that the original entry remains legible.  The 
correction then has to be made right next to the entry and confirmed by date and 
initials of the person making the correction.  Corrections that cannot be made in this 
fashion have to be explained in a detailed statement (e.g. Data Clarification Form), 
reference to which must be documented on the relevant CRF page(s). Do not erase, 
overwrite, or use correction fluid on the original.  All data printouts should be attached 
to the pertinent CRF pages. 
The CRF for each subject must be reviewed and signed by the principal investigator.  
This should be done as soon as possible after each subject completes the study 
(Subject Data Lock).  The Principal Investigator will make the CRF pages available for 
review and collection by the study monitor at each scheduled monitoring visit. A Fidmi 
(or CRO representative) study monitor will review the CRFs and compare the content 

 
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versus the source data.  All CRFs and other pertinent records will be kept during and/or 
upon completion of the study for the number of years indicated by the Israeli law  . 
The Investigator or designated colleague will provide access to the Monitor or other 
designated monitor for the periodic review of source documents (e.g., hospital and 
clinic records) to assure accuracy and completeness of the CRFs. The investigator also 
must maintain and submit, if required, all incomplete CRFs that reflect subject 
experience with the PEG insertion procedure, including retrievable data on subjects 
who withdraw before completion of the study.   
13.5.4 Document Retention 
The investigator or the sponsor shall retain copies of the approved protocol, 
completed CRFs, informed consent documents, relevant source documents, the 
investigator site file, investigators CV, all documents signed by the Shaare Zedek 
University Medical Center and all other supporting documentation related to the 
project for a minimum of seven years. 
Other information to be retained includes: 
• List of committee members who reviewed the application for approval of the 
clinical trial. 
• Documents submitted for review such as all the application documents, 
including the documents submitted to the Ethics Committee for approval 
Investigator/Institution/Sponsor will take measures to prevent accidental or 
premature destruction of study documents. If the investigator is unable to retain the 
study documents for the required amount of time, the Galilee Medical Center or 
designee must be informed of the individual who will be assuming this responsibility. 
 

 
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13.5.5 DEVICE ACCOUNTABILITY  
Accountability records must be maintained at the site at all times. The identification 
number of the subject, the supply/shipment date, lot number, expiry date, usage and 
disposal date of the Fidmi device and the date and quantity of devices returned will 
be recorded and maintained by the PI.  
At study conclusion, all devices (used and unused) must be returned to the sponsor or 
sponsor’s designee for destruction and documented evidence of destruction should 
be available. Ancillary supplies may not have to be returned.  
Upon Fidmi/Fidmi designee visit at the site, accountability of the returned devices 
should be performed and recorded. 
 
 
 

 
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