Single Site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
Phase: NA
Conditions: Feeding Tube Complication
Sponsor: Eric Yudelevich

 
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SINGLE SITE, PROSPECTIVE, PHASE I STUDY, SAFETY 
AND EFFICACY OF ENTERAL FEEDING TUBE STOMA 
SITE ACCESSORY 
 
 
 
Principal Investigator: Eric Yudelevich Blumrosen, MD 
Cleveland Clinic 
9500 Euclid Ave G10 desk 
Cleveland, OH 44195 
Funded by:  Cleveland Clinic Innovations 
Version Number:  V3_11JAN2023 
NCT 05288556 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents  
Study Personnel 
 
 
 
 
 
 
 
 
page 4-5 
Definitions   
 
 
 
 
 
 
 
 
 
page 6-7 
Acronyms 
 
 
 
 
 
 
 
 
 
page 7 
Protocol Synopsis 
 
 
 
 
 
 
 
 
page 8-10 
Purpose and Background 
 
 
 
 
 
 
 
page 10-11 
Risk Assessment and Expected Benefits   
 
 
 
 
 
page 11-13 
 
Adverse Events 
 
 
 
 
 
 
 
page 13 
Study Accessory and Technique Description  
 
 
 
 
page 14 
Design  
 
 
 
 
 
 
 
 
page 14-15 
Product Information  
 
 
 
 
 
 
page 15 
 
Study Intervention Administration 
 
 
 
 
 
page 16 
 
Instructions for Use 
 
 
 
 
 
 
 
page 17-19 
Labeling 
 
 
 
 
 
 
 
 
page 20 
Manufacturing Information  
 
 
 
 
 
page 21 
Schedule of Events 
 
 
 
 
 
 
 
 
page 22-23 
Number of Patients 
 
 
 
 
 
 
 
 
page 23 
Study Duration 
 
 
 
 
 
 
 
 
page 23 
Patient Characteristics 
 
 
 
 
 
 
 
page 24 
 
Inclusion/Exclusion 
 
 
 
 
 
 
 
page 24 
Concomitant Therapy  
 
 
 
 
 
 
 
page 24-25 
Subject Recruitment and Informed Consent Process 
 
 
 
page 25-26  
Study Diagram   
 
 
 
 
 
 
 
 
page 27 
Subject Follow-up 
 
 
 
 
 
 
 
 
page 28-29 
Screen Failure and Early withdrawal  
 
 
 
 
 
page 29-30 
Costs/Compensation  
 
 
 
 
 
 
 
page 30-31 
Primary Outcome Measures  
 
 
 
 
 
 
page 31-32 

 
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Hypothesis Testing 
 
 
 
 
 
 
 
 
page 32 
Data Collection and Analysis   
 
 
 
 
 
 
page 32 
Safety and Monitoring   
 
 
 
 
 
 
 
page 33 
References 
 
 
 
 
 
 
 
 
 
page 34-35 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Personnel 
Regulatory:  
Contact Name:  
Principal Investigator: 
Protocol Development,  Subject 
eligibility, Consent,   
Research Visit, Adverse events  
 
Eric Yudelevich-Blumrosen , MD  
Cleveland Clinic 
Internal Medicine and Geriatrics 
9500 Euclid Ave/G10 
Cleveland, OH 44195 
Office: 216 445-6914  
Mobile: 216 633-1678 
email: YUDELEE@ccf.org 
Co-Investigator: 
Subject eligibility, Consent,   
Intervention,  Research Visit 
Adverse events 
Matthew Allemang,  MD  
Cleveland Clinic 
DDSI General Surgery 
Crile Building/ A100 
2049 East 100th Street  
Cleveland, OH 44195 
Office: 216 518-3650  
Mobile: 216 218-5586 
email: ALLEMAM@ccf.org 
Co-Investigator: 
Subject eligibility, Consent,   
Intervention, Research Visit,  
Adverse events 
Matthew Kroh, MD 
Cleveland Clinic 
DDSI General Surgery 
Crile Building/ A100 
2049 East 100th Street  
Cleveland, OH 44195 
Office: 216 445-7410 
Mobile: 216 339-1162 
e-mail: KROHM@ccf.org 
Co-Investigator: 
Subject eligibility, Consent,   
Intervention, Research Visit,   
Adverse events 
Ryan Plescia, PA-C  
Cleveland Clinic 
DDSI General Surgery 
Crile Building/ A100 
2049 East 100th Street  
Cleveland, OH 44195 
Office/Mobile: 216 217-3212  
e-mail: PLESCIR@ccf.org 
Co-Investigator: 
Subject eligibility, Consent, Research 
Visit, Adverse Events 
Berri Burns, Med, RD, LD, CNSC 
Cleveland Clinic 
Center for Connected Care 
Infusion Pharmacy/ RK30 
6801 Brecksville Rd 
Independence, OH 44131 
Office/Mobile: 216 218-2723 
e-mail: BURNSB3@ccf.org 

 
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Site Coordinator: 
Subject eligibility, Consent, Registration 
Forms,  Regulatory, Data Capture & 
Oversight, Administrative 
Linda Libertini 
Cleveland Clinic 
9500 Euclid Ave/G10 
Cleveland, OH 44195 
Office:216‐448‐8339      
e‐mail: LIBERTL@ccf.org  
 
Site Coordinator: 
Subject eligibility, Consent, Registration 
Forms,  Regulatory, Data Capture 
Administrative 
Jacqueline Fox, RN 
Cleveland Clinic 
9500 Euclid Ave/G10 
Cleveland, OH 44195 
Office:216‐ 444-4590 
e‐mail: foxj6@ccf.org 
Safety Officer (SO):   
Quarterly Assessment of Adverse and 
Serious Adverse Event reporting  
Matthew Pappas, MD 
Cleveland Clinic 
Hospital Medicine 
9500 Euclid Ave/G10 
Cleveland, OH 44195 
Office: 216-444-5633 
e-mail: PAPPASM@ccf.org 
Proto Labs, Inc. 
Accessory Manufacturer 
Brian Lach 
Sr. Account Manager 
Proto Labs, Inc. 
5540 Pioneer Creek Dr. 
Maple Plain, MN 55359 
Office Phone: 877-479-3680  
Direct: 612-404-3866 
Brian.Lach@protolabs.com 
 
 
 
 
 
 
 
 
 

 
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Definitions 
Aspiration:  Inhalation of gastric contents into the lungs.   
Body temperature norms: A temperature over 100.4°F (38°C) most often means you have a fever caused 
by an infection or illness. Normal body temperature varies by person, age, activity, and time of day. The 
average normal body temperature is generally accepted as 98.6°F (37°C). Some studies have shown that 
the "normal" body temperature can have a wide range, from 97°F (36.1°C) to 99°F (37.2°C). 
 
Cellulitis: Skin infection 
Dermatitis: Irritation of the skin. 
Device Migration/Buried Bumper: Uncommon complication of PEG when the internal fixation device  
migrates alongside the stoma tract out of the stomach. 
Erosion: An erosion is an eating away of a surface.  For example, a skin erosion is a loss of part or all of 
the epidermis (the outer layer) leaving a raw, sensitive surface. 
 
Gastrocolocutaneous fistula: A rare complication of PEG, which occurs when a PEG tube penetrates the 
interposed colon between the abdominal wall and the stomach during the initial insertion of PEG 
 
Hemorrhage:  A heavy discharge of blood from a blood vessel.  A hemorrhage may be "external" and 
visible on the outside of the body or "internal," where there is no sign of bleeding outside the body. 
 
MyChart: Electronic platform for secure patient access to electronic medical records  
 
Necrosis: Irreversible injury to cells as a result of encounters with noxious stimuli invariably leads to cell 
death. Such noxious stimuli include infectious agents (bacteria, viruses, fungi, parasites,) oxygen 
deprivation or hypoxia, and extreme environmental conditions such as heat, radiation, or exposure to 
ultraviolet irradiation. The resulting death is known as necrosis, a term that is usually distinguished from 
the other major consequence of irreversible injury, known as cell death by apoptosis 
 
Necrotizing fasciitis:  A type of soft tissue infection. It can destroy the tissue in your skin and muscles as 
well as subcutaneous tissue, which is the tissue beneath your skin. 
Necrotizing fasciitis is most commonly caused by an infection with group A Streptococcus, commonly 
known as “flesh-eating bacteria.” This is the fastest moving form of the infection. When this infection is 
caused by other types of bacteria, it typically doesn’t progress as quickly and isn’t quite as dangerous. 
 
PEG: percutaneous endoscopic gastrostomy 
 
Percutaneous: An approach or entry by puncture or minor incision, of instrumentation through the skin 
or mucous membrane and any other body layers necessary to reach and visualize the site of the 
procedure. 
 
Peritonitis:  Inflammation of the peritoneum, the membrane that lines the inner abdominal wall and 
covers the organs within the abdomen, usually due to a bacterial or fungal infection. 
 

 
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Stoma:  An opening on the abdomen that can be connected to your digestive system.  It may lie fairly flat 
to your body or protrude out. 
 
Tissue Granulation:  Also known as connective tissue or scar tissue that forms on the surface of a wound 
when the wound is healing.   *If too much granulation tissue forms, leaving an excess of bumpy, shiny, 
red tissue, this can actually hinder the healing process and lead to a long-lasting wound. 
Acronyms 
AE:  
Adverse Event (See also SAE) 
 
C5: 
Cleveland Clinic Coordinating Center for Clinical Research or C5: C5Research, Cleveland Clinic 
Coordinating Center for Clinical Research, is an associated research organization (ARO) that provides 
clinical trial services to the pharmaceutical, biotechnology, and medical device industries. 
DPEJ:  Direct percutaneous endoscopic jejunostomy 
EN: 
Enteral Nutrition is nutrition therapy where liquid formula or food is delivered to the 
gastrointestinal (GI) tract to supplement or provide all caloric intake by a tube for patients with a 
functional GI tract. 
FDA: 
Food and Drug Administration 
HEN: 
Home enteral nutrition is EN delivered in the home setting 
IRB:  
Institutional Review Board.   An independent body constituted of medical, scientific, and 
nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-
being of human subjects involved in a trial by, among other things, reviewing, approving, and providing 
continuing review of trials, of protocols and amendments, and of the methods and material to be used in 
obtaining and documenting informed consent of the trial subjects. The Cleveland Clinic IRB has the 
authority to approve, require modifications to secure approval and disapprove all research activities 
overseen and conducted by the organization. CC employee may not conduct human based research if the 
CC IRB has not approved it.    
PEG: 
Percutaneous endoscopic gastrostomy and PEGJ, with jejunal extension is an endoscopic medical 
procedure in which a tube (PEG tube) is passed into a patient's stomach through the abdominal wall, most 
commonly to provide a means of feeding when oral intake is not adequate. 
PROMIS 10: A 10 question patient reported outcomes measurement of quality of life  
QOL:  Quality of Life 
SAE:  
Serious Adverse Event  
SOC: 
 Standard of Care 
WOCBP: Women of Childbearing Potential  

 
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Protocol Synopsis 
Study Title 
Single site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding 
Tube Stoma Site Accessory  
Investigational 
Accessory 
Cleveland Clinic Innovations: Provisional Patent filed with drafted Claims: 
Serial No. 62/736,637 with U.S. Patent Office on SEP 26, 2018 
Sponsor-
Investigator 
Eric Yudelevich Blumrosen, MD 
Cleveland Clinic 
9500 Euclid Ave, G-10 
Cleveland, OH 44195 
Department of  Internal Medicine and Geriatrics 
Office: 216 445-6914  
Mobile: 216 633-1678 
Yudelee@ccf.org 
Study Purpose 
The purpose of the study is to collect safety and efficacy data on the 
performance of the study stoma site accessory when used to prevent 
abdominal wall leakage for patients with a long term feeding tube.   
This accessory has been developed by the Cleveland Clinic and will be used 
for the first time in human subjects according to the labeled indication for 
clinical use in accordance with the Manufacturer’s Instructions for Use based 
on other similar, FDA approved gastrostomy and jejunostomy enteral 
feeding tube accessory components. 
After providing informed consent, eligible patients will receive a study stoma 
site accessory during a feeding tube replacement procedure the patient is 
scheduled to have as a standard of care procedure. 
Study Design 
Single site, prospective, phase I, non-randomized safety and efficacy of 
feeding tube stoma site accessory for patients with enteral feeding tubes. 
Primary 
Endpoints 
Safety and efficacy of the study stoma site accessory as evidenced by 
successful study accessory placement at time of initial replacement procedure, 
post procedure adverse events including recurrence of any documented pre-
procedure [abdominal surface] condition and repeat intervention up to 6 
months after the initial replacement procedure. 
Secondary 
Endpoints 
Patient Quality of Life is hypothesized to improve significantly with leak 
reduction, therefore various Quality of Life questionnaires will be collected 
at baseline, 2 weeks and 6 months or early termination.   
 
Patient 
Population 
Inclusion Criteria: 
• 
Male or female, aged ≥22 and ≤85. Note: Because the study 
accessory is designed for adult use, participants <22 years of age are 
excluded but will be eligible for future trials, if applicable. 
• 
Ability to understand and the willingness to sign a written informed 
consent document. 

 
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• 
Patients with existing gastrostomy and  jejunostomy  enteral feeding 
tubes, placed ≥ 3 months, undergoing replacement of feeding tube 
inpatient or outpatient. 
• 
Willing to adhere to placement of study stoma site accessory and 
ability to take oral temperature at specified times. 
• 
Stated willingness to comply with all study procedures and 
availability for the duration of the study. 
• 
Willing to adhere to removal of study stoma site accessory at mo. 6 
Exclusion Criteria 
• 
Patient requires general anesthesia in an OR for tube changes 
• 
Current use of steroids (any dose) daily ≥ 3 months including, but not 
limited to: prednisone, prednisolone, methylprednisolone, 
cyclosporine 
• 
Current use of Immunosuppressants including, but not limited to:   
azathioprine, mycophenolate. 
• 
BMI ≥ 40 
• 
Non-English speaking patients.  
• 
Pregnant Women. 
• 
Known allergic reactions to components of the study stoma site 
accessory:  Medical Grade Silicone as described in Technical Data 
Prospectus from Dow Corning Corporation.    
• 
Treatment with another investigational drug or device within 6 
months of screening/baseline. 
• 
Uncontrolled illness, recent open abdominal surgery or social 
situations that in the opinion of the investigative team would limit 
compliance with study requirements, including, but not limited to:  
o Ongoing or active infection  
o Psychiatric illness  
o Unable to self-report 
o Not ambulatory and incapable of carrying out all self-care 
• 
Unsuccessful study accessory placement at initial replacement 
procedure 
Number of 
Subjects 
The study will enroll until 10 patients have had successful study stoma 
site accessory placement and reached the 2 week research follow-up 
visit.   
Number of Sites 
1 
Sample Size 
Justification 
 
The sample size is 10 subjects.  No formal sample size calculations were 
performed for pre-market safety and efficacy data.  
Study Hypothesis  
The study is a pilot trial to access feasibility and safety with the aim to 
improve patient quality of life using pre and post measures.  Patient quality 
of life assessment will be collected at baseline and 6 months for comparison.  

 
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Duration of Study 
Expected enrollment period is 12 months. Follow-up duration is 6 months 
from initial replacement procedure with follow-up research visit at week 2 
and phone calls at weeks 4 and 6 and month 6 and research visits at months 
3, 4 and 6. The study will conclude 6 months from the enrollment of the last 
subject. 
Study Monitoring 
Site monitoring will be performed internally by Cleveland Clinic Clinical 
Research Personnel. 
 
Purpose 
 
The purpose of the study is to collect safety and efficacy data on the performance of the study stoma site 
accessory when used to prevent abdominal wall leakage for patients with a long term, ≥ 3 months, enteral 
feeding tube including, gastrostomy or jejunostomy tubes.  This study accessory has been developed by 
the Cleveland Clinic (CC) for clinical use in human subjects and will be used according to the labeled 
indication and in accordance with the Manufacturer’s Instructions for Use based on other similar, Food 
and Drug Administration (FDA) approved enteral tube stoma site accessory components.  Patients 
receiving the study accessory will also be asked pre-procedure and post-procedure quality of life questions 
to identify change in quality of life.   After providing informed consent, eligible patients will receive a study 
stoma site accessory during an upcoming enteral tube replacement procedure the patient is scheduled to 
have as a standard of care procedure. 
Background 
Nutrition therapy where liquid formula or food is delivered to the gastrointestinal tract to supplement or 
provide all caloric intake by a tube for patients with a functional GI tract is known as enteral nutrition (EN).   
Since the first use of endoscopic gastrostomy tube for EN was documented in late 1970 by Gauderer et 
al.[1] use of several additional types of feeding tubes have been widely reported.  Tubes, such as, 
percutaneous endoscopic gastrostomy (PEG,) PEG with jejunal extension (PEGJ) and direct percutaneous 
endoscopic jejunostomy (DPEJ)  have been reported to offer long term solutions for nutrient and 
medication delivery to patients  with intact and functional GI tracts [2] who have a variety of underlying 
diseases.  Design modifications allowing the placement procedure to be technically easier and safer have 
been made over the years but very few modifications have been made to the kit component parts 
throughout this same period of time. [2]      
 
The study stoma site accessory, for regulatory purposes, can be considered an accessory to a newly 
replaced feeding tube. The accessory materials and method of use are substantially similar to 
commercially available feeding tubes used with PEG, PEGJ and DPEJ. We believe that, since the study 
stoma site accessory attaches to the external portion of a newly replaced feeding tube at a previously 
established stoma site and inserts 1 cm into the stoma, which is not as deep as the actual feeding tube, it 
poses no significant risk to its users. By potentially decreasing the leakage from the edges of the tube and 
the friction of the tube against the skin, it does not pose a risk of local infection. It is made of commercially 
available, FDA cleared materials commonly used for enteral feeding tubes and tube components that the 
patient already has in place. The study accessory will be sterilized and packaged at the Cleveland Clinic 
through a validated process and provided specific numerical identification for documented tracking.    
 

 
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This study will evaluate the safety and efficacy of the study stoma site accessory used in place of a 
commercially available feeding tube accessory, i.e., button or flange, at the time of a standard of care 
replacement procedure the patient is scheduled to have at Cleveland Clinic’s Main Campus. Patients 
enrolled in the study will participate for a period of 6 months with outcomes assessed using our protocol 
patient questionnaires. The length of the study will be approximately 12-18 months to allow for 
recruitment, and 6 months of ongoing follow-up after the last patient is enrolled. 
 
 
KNOWN POTENTIAL RISKS  
 
The literature supports that the number of patients with enteral feeding tubes is increasing. [3] [4]  
Although enteral feeding tubes are considered to be a safe intervention that can be placed in an 
outpatient setting or, at the patient’s hospital bedside, procedure-related complications are common. 
[5] The type and frequency vary depending on the specific access route of the enteral feeding tube but 
all complications fall into four major categories: mechanical, gastrointestinal, infectious, and metabolic. 
[6] Overall, complications associated with percutaneous endoscopic gastrostomy vary from 16% to 70%, 
though the majority of these are minor. [7]  
 
Complications, such as maceration from leakage of gastric contents around the tube [7] resulting from a 
mechanical problem, e.g., secondary displacement of the feeding tube,  is a problem described as a 
minor complication, however, it is a common complaint and a major symptom that causes the patient, 
family or caregiver to request a gastrostomy feeding tube change.  Upwards of 78% of patients with 
long-term gastrostomy tube placement report leakage and 12%-39% of these patients consider it 
problematic.[5]  Leakage frequently occurs within a few days of a gastrostomy tube placement  but may 
occur at any time in patients with a mature gastrostomy tract.  Management of co-morbidities and 
measures to address skin breakdown are cited as common treatment. [6]    
 
Participating study patients are anticipated to include a broad range of disease processes for which they 
will be receiving EN or home enteral nutrition (HEN). Significant patient co-morbidities and their 
underlying challenges, which contribute to the 1%-3% of reported major complications [5] will be taken 
into consideration for study patients and their continuing medical care and reporting of adverse events.  
However, major complications requiring repeat intervention compromising the study stoma site 
accessory will result in early termination of patient participation.  The study will focus on the known 
minor risks of tube leakage [5] associated with feeding tube components.   
 
Minor 
• 
Tube leakage 
o Stoma site abdominal surface complications 
▪ 
Contact irritation/dermatitis 
▪ 
Cellulitis 
▪ 
Tissue granulation 
▪ 
Redness/tenderness 
▪ 
Pain at stoma site 
▪ 
Local infection 
▪ 
Bleeding  
▪ 
Necrosis 
 

 
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• 
Tube blockage 
• 
Pain at the PEG site 
 
 
Major Risks 
• 
Aspiration 
• 
Peritonitis 
• 
Hemorrhage 
• 
Device Migration/Buried Bumper Syndrome   
• 
Gastrocolocutaneous fistula 
• 
Wound Infection 
• 
Necrotizing fasciitis 
• 
Inadvertent removal of PEG tube  
 
Unknown Risk 
 
• 
Allergic Reaction 
• 
Long term risks 
 
 
KNOWN POTENTIAL BENEFITS  
 
Enteral access placement and replacement is possible without requiring patient hospital admission. [9]   
Nutrition therapy administered to outpatients is known as home enteral nutrition (HEN).   Studies reveal 
significant clinical benefits with EN and HEN support, including improved wound healing, reduction in 
complications and overall improvement in clinical outcomes and mortality.[8]  Due to these benefits, the 
prevalence of HEN continues to increase worldwide.[8] In the United States, it has been more difficult to 
ascertain the prevalence of HEN given our healthcare insurance model of Medicare and commercial 
providers, but as recently as 2013, was reported to have increased from 463 per million population in 
1995 to 1385 per million.[8][9]  
 
Review of literature includes considerably less on patient’s perspectives concerning the role of enteral 
tube feeding and how the associated complications effect quality of life (QOL).  A 2019 systematic 
literature review examining the role of enteral tube feeding on patients’ QOL [10] supports the notion 
that even though patient’s medical conditions greatly influence their outcomes, enteral feeding tubes 
are effective in improving patients’ QOL. [10]   
 
Our study aims to reduce the complication of tube leakage through modified component design 
allowing better adherence, flexibility and management of the enteral feeding tube device. The 
adjustment of study stoma site accessory management is expected to improve clinical outcomes by 
reducing stoma site abdominal surface complications, reducing frequency of emergency room visits, 
unplanned physician visits and hospital admission and improving the patient and caregiver experience 
and quality of life.      
 
• 
Reduction of stoma site abdominal surface complications 
o Blanching cellulitis 
o Bleeding  

 
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o Contact irritation/dermatitis 
o Erosion/Skin breakdown  
o Local infection 
o Necrosis 
o Pain at stoma site 
o Redness/tenderness 
o Tissue granulation 
• 
Consistent nutritional support  
• 
Fewer emergency room visits or hospital admissions  
• 
Improved quality of life    
o Fewer dressing changes 
o Less discomfort and pain  
o Improved social opportunities 
o Improved psychological outlook 
 
 
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Factors believed to influence risks and benefits impacting patient outcomes for the identified categories 
of complications, e.g., mechanical, gastrointestinal, infectious and metabolic, are influenced by 
differences in types of gastrostomy tubes and enteral feeding methods as well as by individual patient 
medical conditions. [10]    
 
Our study will include patients with these varying influences, anticipating adverse events (AEs) will vary 
widely.  Consequently, AEs will potentially impact study participation following the initial feeding tube 
replacement procedure with the use of the study stoma site accessory. 
 
Adverse Events and Serious Adverse Events Reporting  
 
The study will collect and document Adverse Events (AEs) and Serious Adverse Events (SAEs) for the 4 
major groups associated with EN feeding tubes , mechanical, gastrointestinal, infectious, and metabolic, 
during the entire study period for relationship to the study stoma site accessory and for reporting to the 
Institutional  Review Board (IRB) according to the IRB guidelines.  AEs that are determined by the Principal 
Investigator, or his/her designee to be related or possibly related to the study accessory will be 
documented with focus on the safety and efficacy of the accessory.  If the Principal Investigator, or his/her 
designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for 
any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is 
replaced by a commercially available accessory, the patient will be exited from the study by early 
termination.  All AEs will be treated or referred to a medical specialist for standard of care treatment the 
same as if the patient was the recipient of a commercially approved accessory. 
 
There may be no direct benefit to the patient. The study accessory materials and method of use is 
intended to reduce stoma site leakage that causes abdominal surface complications, thus improving 
functional outcomes with less complications and improved quality of life when used with replacement of 
commercially available PEG, PEGJ and DPEJ tubes.  Potential for outcomes improvement extends to 
patient safety, patient and caregiver quality of life [6] and financial improvement since loss of enteral 
access functionality diminishes patient safety and results in financial losses to healthcare systems with 
additional visits to emergency rooms or hospital admissions [6] [11.]    

 
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Study Accessory and Technique Description 
OVERALL DESIGN 
 
Fig 1. From Left; ribbed accessory plug, retention bumper side view and view from top    
 
This is a single site, prospective, phase 1 pilot study designed to evaluate the safety and efficacy of the 
study stoma site accessory when used to prevent abdominal wall leakage for patients with a long term, ≥ 
3 months, enteral feeding tube, including gastrostomy or jejunostomy tubes.  Outcomes of these patients 
will be evaluated based on collected measures of successful study accessory placement, incidence of 
reported adverse events and quality of life measures.   Patients enrolled in the study will participate for a 
period of 6 months with outcomes assessed using our protocol patient questionnaires. The length of the 
study will be approximately 12-18 months to allow for recruitment, and 6 months of ongoing follow-up 
after the last patient is enrolled. 
 
Proof of concept testing on the study stoma site accessory showed the accessory is effective at preventing 
leakage.  Prototypes for the test were constructed by Cleveland Clinic Medical Device Solutions.  A bench 
model of an artificial bladder with a balloon inside was used to simulate a stomach (Fig 2).  
 

 
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Fig 2. Control test without study accessory 
For the control, a low profile feeding tube was placed in the stoma site without the study accessory.  The 
bladder was filled with yellow dyed water and the balloon was inflated to increase pressure to the point 
of leakage.   
In the control test without the study accessory, there was no pressure change nor build up because 
leakage occurred immediately through the space between “stoma” and the tube (Fig 2).  For the bench 
test, the low profile feeding tube end was inserted into the study stoma site accessory and the assembly 
was placed in the bench model.  With the study stoma site accessory, the bench model was pressurized 
up to 100mmHg. No leakage formed at the “Stoma Site.” Leakage was seen from other parts of the model, 
such as the screws (Fig 3).  
 
Fig 3. Test setup with study accessory  
 
 

 
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PRODUCT INFORMATION 
 
• 
Custom components: Accessory retention bumper and plug with introducer  
• 
Material: Dow Corning® QP1-250 Liquid Silicone Rubber 
• 
Manufacturing: Injection molded in soft, medical-grade silicone. Two-part, platinum catalyzed. 
• 
Quality: Raw materials are lot traced by ISO 9001-certified manufacturer, Proto Labs 
• 
Biocompatibility: Raw material has been tested by the manufacturer to USP Class VI 
biocompatibility standards including: 
o Cytotoxicity 
o Skin Sensitization 
o 7-Day Implantation (systemic toxicity) 
• 
Sterilization: Liquid silicone rubbers are regularly used in implanted medical devices subject to 
ethylene oxide sterilization. ETO has been demonstrated to have no adverse effects on the 
material. [12] [13] 
 
 
STUDY INTERVENTION ADMINISTRATION 
 
 
The study stoma site accessory consists of two components made of silicone elastomers specifically 
designed for the fabrication of medical devices and device components.  The study stoma site accessory 
is compatible with commercially available enteral nutrition feeding tubes ranging from 16F to 20F and is 
intended for use during EN feeding tube standard practice replacement procedures.   A rigid introducer, 
also made of silicone elastomers is included with each study accessory retention bumper and plug.   The 
accessory components are supplied by Proto Labs and intended for one-time use.   All three components 
will follow the ETO sterilization process and will be packaged and labeled as individual kits for 
accountability.  
 
 
Fig.4   Stoma site accessory retention bumper and plug shown with SOC feeding tube  
 
 
 

 
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Instructions for use: 
 
It is recommended that the tube French size selected be similar in size to the tube being removed, 
unless otherwise indicated by the physician. For questions or information about the tube’s Instructions 
for Use (IFU) and a list of complete complications, please refer to the specific manufacturer’s 
Instructions for Use.  The following steps (1 through 5) are generalizable and not specific to any single 
manufacturer’s IFU:  
 
1. Select the appropriate size tube, remove from the package and inspect for any visible defects.  
 
2. Using the manufacturer’s specific type syringe, inflate the balloon through the balloon port 
using the specified mL units of sterile or distilled water for a standard balloon.  
 
3. Remove the syringe and verify balloon integrity by gently squeezing the balloon to check for 
leaks.  Visually inspect the balloon to verify symmetry. Symmetry may be achieved by gently 
rolling the balloon between the fingers. Reinsert the syringe and remove all the water from the 
balloon.  
 
4. Using the syringe, flush water through balloon port to verify patency.  
 
5. Lubricate the distal end of the tube with water-soluble lubricant. Do not use mineral oil or 
petroleum jelly.  
 
The following steps (6 through 14) are specific to incorporating the accessory placement subsequent 
to the standard Instructions for Use for tube placement.  It is recommended that the accessory plug 
size selected be compatible in size to the tubing French size being placed, e.g., 16 Fr.  The accessory 
plug component will be in a separate package, labeled by size compatibility.  One retention bumper 
and one introducer will share one package since they are identical respectively in size.   
 
6. Remove the selected accessory components from sterile packaging and inspect for any visible 
defects.  If defects are observed, do not use.  Obtain another package.  
 
7. Place retention bumper over proximal end of plug. 
 
8. Slide the retention bumper so it is seated within the indentation at the proximal end of the 
accessory (see figure 5 below.) 
 
9. Lubricate the Introducer with water-soluble lubricant. Do not use mineral oil or petroleum jelly. 
 
10. Insert the proximal end of the Introducer (which is the slimmer end) into the distal end of the 
tube until the flared end of the Introducer is abutted to the end of the tube (see figure 6.) 
 
11. With the Introducer in place, orient the plug so the proximal end is inserted first over the 
tapered Introducer. 

 
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Fig 5 
              
 
 
 
 
Figs.6  
 
 
 
     
        
 
 
          
From left, Introducer used to pull through SOC feeding tube to finished assembly with Introducer 
removed and the stoma site accessory plug in place at the right position. 
 
 
12. Continue sliding the plug through the Introducer’s body until it reaches the shaft of the tube and 
is at least an inch away from the Introducer.  
13. Remove the Introducer from the lumen of the tube. 
14. Refer to the specific manufacturers IFU to insert the tube in the stoma track and to inflate the 
balloon of the tube.    
  

 
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15. Once tube has been placed and the balloon inflated to recommended capacity, place the 
accessory plug and position the bumper so that it is in contact with the skin to ensure secure 
placement. 
 
16. Check around the stoma for gastric leakage.  If the stoma leaks, follow the manufacturer’s 
recommended instructions to adjust balloon fill volume.  
17. Follow the standard procedural guidelines for cleansing the skin around the stoma site. 
For tube care instructions, nutrition and medication administration, refer to the specific tube 
manufacturer’s Instructions for Use.   
Description of each component:  
 
▪ 
Stoma site accessory plug  
o Surrounds the feeding tube 
o Curvature and ribs to prevent accessory component from migrating  
o Indented to retention bumper  
 
▪ 
Retention accessory bumper  
o Cupped, to allow greater mobility of flexible tubing 
 
▪ 
Introducer 
o A double tapered plastic rod to assist the stoma site accessory plug onto the 
feeding tube.   One end will insert into the distal end of the feeding tube.   The 
accessory plug will be put onto the opposite end of the introducer and slide 
toward feeding tube. 
 
Duration of implant or exposure     
            
The average life span of PEG tubes is reported to be three months with tube degradation being the 
primary reason for replacement.[5]  The study stoma site accessory is anticipated to be compatible 
with this duration based on similar SOC flange and button accessories.  Maximum duration is unknown 
but could be significantly longer.  Many commercial insurers will cover up to four tube replacements 
per calendar or rolling year.   For study purposes the maximum length of time during which data will 
be collected for tubing change, as ordered by the treating physician, will be 6 months from initial study 
accessory placement.    
 

 
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Fig7. The study stoma site accessory depicting prevention of stomach acid from leaking on the 
abdominal wall. 
 
Labeling/Accessory Tracking 
The study stoma site accessory components will be sterilized by Cleveland Clinic’s OR Surgical Processing 
Department.  One retention bumper and one introducer will share one package since they are identical 
respectively in size.  The accessory plug component will be in a separate package, labeled by size 
compatibility, e.g., “16 Fr, 20 Fr”.  All components will be double wrapped, barcoded and assembled as 
kits.  Kits will be delivered for accountability and storage at room temperature in the Internal Medicine 
Research Unit (IMRU) located on the Cleveland Clinic (CC) Main Campus study site.  Kits will be secured in 
a locked cabinet, accessible only to study personnel.  Study personnel will maintain and monitor usage on 
a Case Report Form.  IMRU study personnel can readily provide the study stoma site accessory kits to any 
procedure area on the Main Campus at short notice.   

 
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Manufacturing Information  
 
 

 
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TABLE 1: SCHEDULE OF EVENTS  
Evaluation   
Screening  
/ Baseline  
  
Day 1  
Week 2  
 Follow-
Up8, 9     
(+/‐ 3 
days)  
Phone Call  
   Follow-up     
  Weeks 4, 6     
(+/‐ 3 days)  
unscheduled  
Months 
 3 & 4   
Follow-
Up(+/‐ 3 
days)8, 9       
  
Early 
Termination  
1, 7, 8, 10   
  
Month 6  
Follow‐Up 8,9  
(+/‐ 7      
days) 
Informed Consent   
X   
  
   
   
 
   
   
Assess Eligibility  
Inclusion/Exclusion  
X   
  
   
   
 
   
   
Enrollment  
X   
  
   
   
 
   
   
General Assessment 
of the Abdomen with  
stoma site 
inspection.    
Vital signs  (Ht, Wt,  
BMI, temp, BP if 
avail) 1,7  
X  
  
X  
   
X  
X  
X   
Quality Of Life 
Questionnaire 
PROMIS 102   
X   
  
  
  
 
X  
X   
Tobacco use 
questionnaire  
X  
  
  
  
 
X  
X  
Characteristics of 
pain and leakage 
questionnaire2  
X  
  
X  
X  
 
X 
X  
X  
Abdominal Pictures3,7 
X   
  
X   
   
X 
  
   
Medications of  
Interest4  
X  
  
  
X   
X   
X 
X   
X  
Accessory Placement 5  
  
X  
  
  
 
  
  
Dispense Oral  
Temperature  
Thermometer and  
Temperature Log6  
X   
  
   
   
 
     
   
   
Review Oral  
Temperature Log6,7  
  
  
X  
  
X 
  
  
Adverse Events   
   
  
X   
X   
X 
X   
X   
Study completion 
telephone follow-up   
   
  
  
  
 
X  
X  
Accessory Removal  
  
  
  
  
 
X  
X  

 
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1. Documentation of general assessment with stoma site inspection and vitals at baseline as standard of care for 
ambulatory services will be collected from the patient’s electronic chart.  Vitals at week 2 and months 3, 4 will be 
collected from the patients chart or as reported by the patient for virtual visits.  Month 6 vitals will be collected  
from the patient’s electronic chart. Documentation of general assessment with stoma site inspection and vitals for 
hospital bedside or ambulatory services  at  early termination between Day 1 and Month 6 follow-up will be 
collected from the patient’s electronic chart.    
2. Month 6 questionnaires can be completed over the phone.  If the patient leaves the study prior to month 6, study 
members will attempt to collect QOL questionnaires PROMIS 10 and characteristics of pain and leakage for 
outcomes reporting. 
3. Abdominal Pictures will be taken using Haiku software on CC issued cellphones and uploaded securely to the 
patient electronic chart. Pictures can be sent by the patient in MyChart for virtual visits scheduled through 
MyChart. Virtual visit abdominal pictures and screen captures are optional if not feasible to obtain at any study 
time points.   Pictures are optional for study participation.    
4. Medications of interest are primarily antibiotics. 
5. Intervention at the study site occurs within 30 days of Informed Consent.   
6. Daily temperature log to be completed by patient on days 3 through 10 and reported at week 2 and at months 3 
and 4. Temperatures are self-recorded for all virtual visits; collection of temperature log is not required.  The 
patient will be asked to call their treating physician if the patient is reporting a temperature over 100.4°F .  
7. General assessment of the abdomen with stoma site inspection occurs at baseline evaluation, week 2 and months 
3, 4 and 6 research visits and early termination. The week 2 and months 3 and 4 research visit may be scheduled in 
person or virtually.  When the exam is virtual, the patient will be asked to report body temperature and vitals and 
allow/provide a visual of the abdomen for assessment and pictures when applicable.  Pictures are optional for 
study participation.    
8. Additional labs, radiology or other medically necessary procedures at week 2, months 3, 4 and 6 or early study 
termination as determined by the attending physician are considered standard of care.  Patients will be asked to 
contact the study coordinator within 48 hours of a qualifying event, e.g., removal of study stoma site accessory 
that occurs at an external medical facility leading to participant early study termination. 
9. Study personnel will schedule a research visit for months 3, 4 and 6   Study visits week 2 and at months 3 and 4 can 
be conducted  virtually or in person.  The month 6 study visit will be conducted in person for purposes of accessory 
removal.   
10. Patients will be asked to contact study personnel to schedule in-person study accessory removal when removal is 
voluntary.   
  
 
  
 
Number of patients 
Ten patients to be recruited at one site, the Cleveland Clinic Main Campus. Patients who are prematurely 
withdrawn prior to week 2 follow-up will be replaced until the total number of patients exceeding week 
2 equals 10.   
Study Duration 
Expected enrollment period is 6 months, follow-up duration is 6 months from initial replacement 
procedure with follow-up visit at week 2 +/- 3 days and phone calls at weeks 4, 6 and early termination 
and months 3, 4 and 6 study visits. The study will conclude at 6 months from the last enrolled patient. 
 
Patients undergoing intervention, surgical or repeat EN feeding tube replacement, after the initial 
replacement procedure that compromises the study stoma site accessory integrity will no longer be 
followed but will be included in the analysis of the endpoints until the time of intervention.    

 
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Stoma site study accessory removal with standard of care enteral feeding tube replacement and patient 
QOLs will be completed at month 6. The Investigator also must provide follow-up medical care for all 
patients who are prematurely withdrawn from the study or, must refer them for appropriate ongoing 
care.  
 
Patient Characteristics 
Inclusion criteria  
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 
• 
Male or female, aged ≥22 and ≤85 Note: Because the study accessory is designed for adult use 
participants <22 years of age are excluded but will be eligible for future trials, if applicable 
• 
Ability to understand and the willingness to sign a written informed consent document  
• 
Patients with existing gastrostomy and  jejunostomy  enteral feeding tubes, placed ≥ 3 months, 
undergoing replacement of feeding tube inpatient or outpatient 
• 
Willing to adhere to placement of study stoma site accessory and ability to take oral 
temperature at specified times  
• 
Stated willingness to comply with all study procedures and availability for the duration of the 
study 
• 
Willing to adhere to removal of study stoma site accessory at month 6 
 
Exclusion criteria  
An individual who meets any of the following criteria will be excluded from participation in this study: 
• 
Patient requires general anesthesia in an OR for tube changes 
• 
Current use of steroids (any dose) daily ≥ 3 months including, but not limited to: prednisone, 
prednisolone, methylprednisolone, cyclosporine 
• 
Current use of Immunosuppressants including, but not limited to:   azathioprine, 
mycophenolate. 
• 
BMI ≥ 40 
• 
Non-English speaking patients 
• 
Pregnant Women 
• 
Known allergic reactions to components of the study  stoma site accessory:  Medical Grade 
Silicone as described in Appendix A: Technical Data Prospectus from Dow Corning Corporation    
• 
Treatment with another investigational drug or device within 6 months of screening/baseline 
• 
Uncontrolled illness, recent open abdominal surgery or social situations that in the opinion of 
the investigative team would limit compliance with study requirements, including, but not 
limited to:  
o Ongoing or active infection  
o Psychiatric illness  
o Unable to self-report 
o Not ambulatory and incapable of carrying out all self-care 
o Unsuccessful stoma site study accessory placement at time of initial replacement 
procedure 
 
 

 
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CONCOMITANT THERAPY 
For this protocol, a prescription medication is defined as a medication that can be prescribed only by a 
properly authorized/licensed clinician. Medications will be reported in the Case Report Form (CRF) 
including concomitant prescription medications.  Concomitant prescription medication will be reviewed 
on an initial basis to confirm eligibility and at weeks 2, 4, 6 and months 3, 4 and 6 or at early termination.   
The independent effects of concomitant therapies will be compared with the study intervention, clinical 
outcomes and patient reported outcomes, pre and post procedure, to ascertain if there are direct effects 
on the study primary and secondary endpoints.     
Patient electronic charts or outside records will be collected for review.    
Use of steroids (any dose) daily ≥ 3 months or Immunosuppressant(s) will be considered an exclusion.  
Following enrollment and successful placement of study stoma site accessory during initial feeding tube 
replacement procedure, medications prescribed will be reported and collected for steroids or 
immunosuppressants including, but not limited to: 
• 
Prednisone 
• 
Prednisolone 
• 
Methylprednisolone 
• 
Cyclosporine 
• 
Azathioprine 
• 
Mycophenolate 
 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Patients at a single site will be recruited over a period of 12 months until recruitment reaches 10 patients 
who have completed the week 2 research visit.  Participation based on referrals will be made by the study 
team investigators and site staff associate physicians who would otherwise refer a patient for a 
replacement enteral feeding tube.   Referring physicians are primarily Gastroenterology physicians who 
have expertise in some of the underlying diseases for which patients are on enteral nutrition therapy and 
may include patients with history of gastroparesis, bariatric bypass procedures or abdominal cancers.   
Study team investigators are represented by internal medicine, geriatrics and general surgery specialties 
who are knowledgeable of these diseases and are knowledgeable of the inclusion/exclusion criteria, 
patient history of illness and medical needs.  General surgery study team members are experienced with 
enteral nutrition feeding tube replacement procedure for the various types of tubes; percutaneous 
endoscopic gastrostomy (PEG,) PEG with jejunal extension (PEGJ) and direct percutaneous endoscopic 
jejunostomy (DPEJ.)  Internal medicine and gastroenterology staff have a solid understanding of the 
complications, needs and management of the patient study population.   The eligible patient population    
will be approached by study personnel both in-patient and outpatient to discuss the Informed Consent 
process  in a manner that assures privacy and confidentiality to ascertain and document that the patient 
acknowledges understanding and agrees to the study requirements.  The procedure will take place within 
30 days of the consent.     
 
 
Patients will include male or female, aged ≥22 and ≤85 with ability to understand and the willingness to 
sign a written informed consent document.  Because the accessory is designed for adult use, participants 
<22 years of age are excluded but will be eligible for future trials, if applicable.  Patients requiring sedation 
for a feeding tube replacement are identified as an exclusion for this phase I, 10 patient, feasibility study. 
 
Women of Childbearing Potential (WOCBP) will be asked at the time of consent if they are known to be 
pregnant.  Known pregnancy is an exclusion due to the inherent physiologic changes of the female 
anatomy during pregnancy and the decreased ability to discern differences between study accessory 

 
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complications and pregnancy complications for analysis.   WOCBP not known to be pregnant will be 
eligible for the replacement study stoma site accessory using standard of care (SOC) precautions and 
electronic chart documentation and will be asked to use an effective method of contraception for the 
duration of study participation = 6 months +/-7 days from study intervention.   Pregnancy testing is not 
required as SOC prior to the accessory replacement procedure or for the study.  Eligible women who are 
scheduled for  EN feeding tube replacement while in the hospital or on an outpatient basis may have a 
pregnancy test at the time of admission or prior to procedure as SOC.  Available results will be collected 
from the electronic chart and if positive for pregnancy, will be considered an exclusion.  Pregnancy after 
accessory placement will not exclude a female patient.  Should a woman become pregnant or suspect she 
is pregnant while participating in this study, she should inform her study physician immediately. Male or 
female patients who have BMI ≥ 40 who present additional risks specifically related to morbid obesity will 
be excluded from the study due to decreased ability to discern differences in confounding risk factors.   
 
All study team members will be trained to perform and document the Informed Consent process as well 
as administer the pre-procedure questionnaires Study personnel will be trained to notify the entire team 
at the earliest opportunity of an Informed Consent and the location and timing of the procedure so that 
the study accessory and oral thermometer can be delivered by trained study personnel to the appropriate 
location, e.g., hospital floor at bedside or endoscopy suite.  Study personnel delivering study stoma site 
accessory and oral thermometer will confirm completion of pre-procedure questionnaires and patient 
understanding of the oral temperature log prior to intervention.  The study accessories will be stored for 
use in a locked cabinet, at room temperature, in the 4C Research office located on site.  From there, it can 
readily be provided to any area on the Main Campus at short notice.  Appropriate documentation of use, 
including identification labels will be maintained by the site coordinator(s) in the 4C Research office on 
the applicable Case Report Form.       
 
Informed Consent Process 
Patients meeting all of the inclusion criteria and none of the exclusion criteria may be invited to participate 
in the study.    .  The study plan, potential risks and benefits of participation in the study and authorization for 
optional abdominal photos at the time of consent, week 2, and months 3 and 4, seen in Table 1, page 22, will be 
explained to all patients eligible for entry into the study.   Patients can be consented up to 30 days in advance 
of their scheduled replacement procedure, using the IRB approved consent.  Patients who require 
sedation for the procedure will not be eligible for the study stoma site accessory.  All patients should be 
familiar with the Informed Consent and its content, and have been given opportunity to have their 
questions answered about the study prior to signing the Informed Consent as well as given the choice to 
decline consent.  Each patient who decides to participate will be required to sign an Informed Consent 
document prior to any study-related procedures, including additional authorization or opt-out for 
abdominal photos.  Patients can sign the Informed Consent in advance and be declined participation on 
the day of procedure if the attending physician determines them unfit for replacement with the study 
stoma site accessory. 
 
If new information is obtained after a patient receives treatment with the device, patients who have not 
exited the study will be informed about the new information and will be re-consented at the discretion of 
the site’s IRB.  
 
Patients will undergo a baseline evaluation including the following:  
• 
General assessment of the Abdomen with stoma site inspection  
• 
Clinical assessments for confirmation of inclusion / exclusion criteria   

 
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ENROLLMENT SCHEMA 
 
An overview of the study activities is presented in Table 1 Schedule of Events 
 

 
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Follow-Up 
Patients are expected to participate in this study for up to 6 months after the index procedure.  The 
follow-up visits and phone calls should occur within the following time frames when possible. Follow-
up time frames are intended as guidelines only. They are not absolute and are not intended to limit 
data collection due to scheduling conflicts.    
 
2 week (14 ± 3 days; 11-17 days after the index procedure)  
4 week (28 ± 3 days; 25-31 days after the index procedure)  
6 weeks(42 ± 3 days; 39-45 days after the index procedure)  
3 month  (84 ± 3 days; 81-87 days after the index procedure) 
4 month (112 ± 3 days; 109-115 days after the index procedure) 
6 month (180 ± 7 days; 173-187 days after the index procedure)  
 
The follow-up visit at 2 weeks can be scheduled as in-person or a virtual visit and will include: 
• 
General Assessment of the abdomen with stoma site inspection  
• 
Characteristics of pain and leakage questionnaire 
• 
Abdominal Pictures 
• 
Medications of Interest   
• 
Oral Temperature Log Review 
• 
Oral Temperature  
• 
Adverse events 
 
 The follow-up phone calls at weeks 4, 6 and after an unscheduled visit will include the following:  
• 
Characteristics of pain and leakage questionnaire 
• 
Medications of Interest   
• 
Adverse events 
 
The follow-up visit at months 3 and 4 will be virtual or in-person and include: 
• 
General Assessment of the abdomen with stoma site inspection  
• 
Characteristics of pain and leakage questionnaire 
• 
Abdominal Pictures 
• 
Medications of Interest   
• 
Oral Temperature 
• 
Adverse events 
 
The follow-up visit at month 6 will be in-person and include: 
• 
General Assessment of the abdomen with stoma site inspection 
• 
Feeding tube change with removal of study device and replacement with SOC tubing 
• 
PROMIS 10 
• 
Tobacco use questionnaire 
• 
Characteristics of pain and leakage questionnaire 
• 
Medications of interest 
• 
Adverse events 

 
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If early termination occurs, study personnel will attempt to collect the following: 
• 
General Assessment of the Abdomen with stoma site inspection  
• 
PROMIS 10 
• 
Tobacco use questionnaire 
• 
Characteristics of pain and leakage questionnaire 
• 
Medications of Interest  
• 
Vitals 
 
Any unscheduled visits discovered during follow-up phone calls or patient reported will be recorded on 
the appropriate case report form (CRF); The reason for the visit, adverse events of interest, treatments, 
interventions, hospitalizations and those resulting in early termination will be captured.   
A Study Completion CRF should be completed at Month 6. The Investigator also must provide follow-up 
medical care for all patients who are prematurely withdrawn from the study, or must refer them for 
appropriate ongoing care.  
 
SCREEN FAILURES 
 
Participants who are consented to participate in the clinical trial, who are scheduled for enteral feeding 
tube replacement with the study stoma site accessory and who are determined by the attending clinician 
investigator at the time of intervention to be inappropriate candidates for anatomical or medical reason, 
e.g., requiring sedation, not previously ascertained during the screening procedures, are considered 
screen failures.   
 
Informed consent language will include description of allowance for the study investigator to determine 
that the patient is not a good candidate after consent and prior to, or at the time of intervention.   
Determination of inappropriateness will be made in the best interest of the patient.  If such determination 
is made, the investigator will identify the decision directly with the patient. The patient will have 
acknowledged and agreed to this decision as part of the Informed Consent process.  The patient will 
understand and agree that no additional financial compensation will be provided if they are considered 
ineligible.  The patient will have acknowledged and agreed to an alternative, standard of care replacement 
or other procedure to be performed in their best interest. 
 
• 
Individuals who do not meet the criteria for inclusion in this trial because of a previously 
undetermined condition of anatomical or medical origin may be rescreened at a later date if, a) 
the study is still recruiting patients b) the previous condition has been resolved.   Rescreened 
participants should be assigned the same participant number as for the initial screening. 
 
Minimal information including demography, eligibility criteria, screen failure details and any adverse 
event or serious adverse event (SAE) from the time of consent up to the intervention will be collected for 
Consolidated Standards of Reporting Trials publishing requirements and to respond to queries from 
regulatory authorities. 
 
EARLY PATIENT WITHDRAWAL/STUDY TREATMENT DISCONTINUATION 
 

 
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A patient may voluntarily withdraw from the study at any time either before or after undergoing the initial 
replacement procedure without prejudice or loss of care. The patient should notify the investigator of 
his/her desire to withdraw.  The Principal Investigator, or his/her designee, or in consultation with 
multiple study team personnel, may also decide to withdraw the patient from the study at any time based 
on medical judgment.  
A patient should be withdrawn from the study if the Principal Investigator believes, or agrees in 
consultation with the study team and/ or Safety Officer recommendation that continuation would be 
detrimental to the patient’s well-being.  Reasons for Study Treatment Discontinuation/Early Patient 
Withdrawal are: 
• 
Withdrawal of Informed Consent, (subject’s decision to withdraw for any reason). 
• 
Any clinically significant AE/SAE(s), laboratory abnormality, and/or concurrent illness which, in 
the opinion of the investigator, indicates that continued treatment with study accessory  and/or 
further participation in the study, is not in the best interest of the subject. 
• 
Significant protocol violation. 
• 
Protocol deviation resulting in significant patient safety risk. 
• 
Subjects who for any reason cannot be followed and/or are unable to meet the requirements of 
the protocol. 
• 
Death after consent 
 
Patients who leave the study prior to month 6 voluntarily will be asked to schedule an in person, early 
termination visit for the study stoma site accessory removal and a standard of care tube replacement.   
 
In all instances of withdrawal, the appropriate study visit and study termination data should be recorded 
in the electronic chart and should include the reason why the patient has been withdrawn from the study. 
Any data collected on the patient up to the point of withdrawal may be used in the analysis. Subjects who 
are prematurely withdrawn from the study prior to week 2 research follow-up will be replaced until 10 
patients have been successfully recruited.  
 
In the event a patient cannot be contacted for follow-up assessments, at least three attempts should be 
made to locate the patient, and these efforts will be documented. If the patient cannot be located, a lost 
to follow-up entry will be submitted for regulatory purposes.  
 
 
COSTS AND COMPENSATION  
 
The study stoma site accessory, week 2 interval assessments and months 3, 4 and 6 follow-up visits will 
be covered by the study, which will not be billed to the patient or their health insurance plan. These 
“research only” services that are paid for by the Clinic include: abdominal assessment not done for 
conventional standard care, removal of the study accessory at month 6 with replacement of standard, 
conventional tubing components and administration of study specific questionnaires. If additional medical 
services are performed  during this research study that are considered to be conventional,  routine clinical 
services that  would have been performed even if the patient were not participating in the research study, 
these will be billed to the health insurance plan or the patient.  Examples of these routine services include 
but are not limited to: CT scans, conventional care, drug and labs not required by the study and additional 

 
Stoma Site Accessory  
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feeding tube changes.  The patient will be responsible for paying any deductibles, co-payments or co-
insurance that are a normal part of their health insurance plan.   
 
The patient may incur some expenses as a result of being in the study, such as hotel, food, bus/taxi fare 
and parking fees when attending scheduled or unscheduled visits. To assist with the cost of time and travel 
associated with study participation at CC, subjects will be paid $50.00 for the completed week 2 interval 
assessment and again at early study termination and  months 3, 4 for completed research visits and month 
6 following removal of the study accessory and  completion of patient questionnaires. Patients will be 
provided a parking voucher for the week 2  and months 3, 4 and 6 study visits attended in-person and 
compensated for their time and effort toward participation at the rate of $50.[Table2]  If, at any time prior 
to month 6, the patient experiences a repeat intervention scheduled at the Clinic with either a feeding 
tube change that requires removal of the study accessory  and results in early termination the patient will 
be compensated at the rate of $50 for their time and effort toward participation and provided a parking 
voucher. The Clinic is paying the study doctors and the study team for their work in this study.   
Subjects will be paid per the schedule below in the form of a check mailed to the patient’s confirmed 
residence. 
 
Study Calendar Visits 
Compensation Amount 
Screening/Baseline visit with Consent   
Day 1 (Accessory Placement) 
   
Week 2 (Research Visit Assessment) 
$50.00   
Week 4 (Phone Call) 
 
Week 6 (Phone Call) 
Month 3 (Research Visit Assessment) 
$50.00   
Month 4 (Research Visit Assessment) 
$50.00   
Unscheduled or Early Termination 
$50.00  
Month 6 (Research Visit with Accessory 
Removal and Completed Patient Questionnaires) 
$50.00   
 Table 2 Overview of participant compensation  
 
In the event of physical injury or illness resulting during participation in the study, medical care is available 
at the Cleveland Clinic, however, the Cleveland Clinic has no plans to provide free care or compensation 
for a patient’s lost wages.  The study participant and/or their insurance carrier will be responsible for all 
expenses related to the injury or illness.  
 
Primary Outcome Measures 
STUDY OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Primary 
 
 
Safety and efficacy of the study 
accessory as evidenced by rate of 
successful device placement and 
related post procedure adverse 
events.     
Rate of procedural success will be 
defined as placement of the device at 
the intended location, including securing 
of the device in place and its 
effectiveness at the week two [2] exam. 
Demonstrate study 
accessory viability; its 
safety and efficacy for 
use in a general 
population of patients 

 
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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
The study will focus on the known 
minor risks of tube leakage 
associated with feeding tube 
components including recurrence 
of any documented pre-procedure 
[abdominal surface] condition, new 
condition or repeat intervention up 
to 6 months after the initial 
replacement procedure. 
Patients will be followed up to 6 months 
after the index procedure.  However, 
any patient who requires re-intervention 
that compromises the study stoma site 
accessory integrity (e.g., study accessory 
is removed and replaced with  standard 
of care components or otherwise 
damaged) subsequent to the initial 
replacement procedure will no longer be 
followed but will be included in the 
analysis of the endpoints until the time 
of re-intervention.    
Rate of post-procedure adverse events 
to be collected from initial replacement 
procedure through month 6, including 
but not limited to:    
• 
Dermatitis 
• 
Cellulitis 
• 
Erosion  
• 
Accessory migration over 1 cm 
• 
An adverse event determined as   
related or possibly related  
• 
Allergic reaction to the accessory 
material 
displaying a broad 
range of disease 
processes for which 
they will be receiving 
EN or HEN for ≥ 3 
months.    
 
  
 
Secondary 
 
 
Change in patient quality of life   
after intervention as self-reported 
by participants.  Outcomes will be 
collected at various intervals.   
Various participant reported outcomes 
will be collected at  baseline, week 2 and 
month 6: 
• 
PROMIS 10, nationally validated 
quality of life survey tool  
• 
Alcohol/ tobacco use 
• 
Study accessory  management 
questions 
• 
Characteristics of pain and leakage at 
site of study accessory placement  
Demonstrated ability 
to predict clinical 
benefit to patients 
with enteral feeding 
tubes.   
 
Table 3 
 
Hypothesis Testing   
This is not a hypothesis driven study.  The study is a pilot trial to determine safety and efficacy of a feeding 
tube accessory and feasibility of determining improvement of patient quality of life using pre and post 
measures. Patient quality of life assessment will be collected at baseline and 6 months for comparison. 

 
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Data Collection and Analysis  
Study related data, including patient reported outcomes and data collected from the patient electronic 
medical record will be entered in a password protected database by study personnel, with oversight by 
Cleveland Clinic Coordinating Center for Clinical Research (C5 Research). C5 Research is an Academic 
Research Organization (ARO.) An ARO, associated with a university and/or hospital, combines clinical and 
academic expertise to independently conduct clinical trials and/or to provide services to trial sponsors in 
the coordination of clinical trials.  To protect the patient privacy, all records will be stored by a patient 
identifier code assigned to the patient at the time of enrollment.  The database will be password 
protected.  Only approved research team members associated with this study will have access to these 
records.  The accumulated data will be analyzed and used for reporting purposes.  Fees associated with 
the data capture and analysis will be paid for by the study with no cost to the patient.  
 
Patient characteristics will be summarized as appropriate descriptive statistics. The primary and 
secondary endpoints will be summarized as frequencies and percentages. Ninety-five % confidence 
intervals will be also computed. We will also compute the lost to follow-up proportions. All analyses will 
be conducted with SAS 9.3 (Cary, NC).  
Safety and Monitoring   
A data Safety Officer (SO) will be assigned to monitor the study data collection, minimally, on a quarterly 
basis.  The Safety Officer will be a CC staff physician, independent of the study team, who will review the 
accumulating data with regard to recruitment, safety and efficacy.  The SO will not be involved in the 
conduct of this study. The data manager will summarize and report data to the SO at least quarterly, who 
will review the report and make recommendations to the investigators.  
 
FDA approved, commercially available enteral feeding tube accessories have not been shown to affect 
mortality. The study stoma site accessory is intended for use with commercially available enteral tubes 
during a standard of care replacement procedure and is not believed to pose significant risk to its users.   
EN feeding tube device replacement is performed at CC in both ambulatory and in-hospital settings for 
patients with varying underlying diseases so, there are expected to be AEs and possible SAEs not related 
to the study stoma site accessory.   
 
The SO will be asked to perform assessment of serious events in aggregate on a quarterly basis but may     
request an unscheduled review at any time for evaluation of causal link between the study stoma site 
accessory and any serious complications, including death.  Serious events that appear to be potentially 
related to the study intervention will be reported to the SO within 24 hours of an investigator becoming 
aware of the event. The SO will be consulted regarding whether or not accrual should be suspended to 
allow for investigation in the occurrence of serious adverse events, particularly for those that are related 
or possibly related to the study accessory.  
 
The primary study coordinator will disseminate the event and results of the SO review with the entire 
study team. 
 
 
 
 
 

 
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