Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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 percutaneous endoscopic gastrostomy (PEG), percutaneous endoscopic gastrojejunostomy (PEGJ) and direct percutaneous endoscopic jejunostomy (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. 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.

Official Title
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Single Site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

Conditions
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Feeding Tube Complication

Intervention / Treatment
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* Device: Placement of stoma site enteral feeding tube accessory


Participation Criteria
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Eligibility Criteria
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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] 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: Ongoing or active infection Psychiatric illness Unable to self-report Not ambulatory and incapable of carrying out all self-care Unsuccessful stoma site study accessory placement at time of initial replacement procedure

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Site, Prospective, Phase I Study, Safety and Efficacy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stoma Site Accessory<br>Stoma site accessory with enteral tube replacement procedure. | Device: Placement of stoma site enteral feeding tube accessory<br>* The study stoma site accessory will be attached at the stoma site during an enteral tube replacement procedure the patient is scheduled to have as a standard of care procedure. The study stoma site accessory is compatible with commercially available enteral nutrition feeding tubes ranging from size 16 to 20 French tubing that are adjustable to variable length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at week 2. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Week 2 Visit | 
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at week 4. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Week 4 Phone call | 
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at week 6. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Week 6 Phone call | 
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at month 3. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Month 3 Visit | 
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at month 4. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Month 4 Visit | 
| Successful Accessory placement | Using the accessory placement date as the baseline, the % of patients with study accessory still in place will be measured at month 6. The measurement tool is a question the patients will be asked to determine Is the device still in place? The response is captured in a database with the answers Yes or No. | Month 6 Visit | 
| Number of feeding tube complications for each patient with a study accessory | Minor complications associated with feeding tubes as defined by clinical assessment of treating physician at week baseline. Total number of complications will be reported per patient at each time point. | Baseline | 
| Number of feeding tube complications for each patient with a study accessory | Minor complications associated with feeding tubes as defined by clinical assessment of treating physician at week 2. Total number of new complications will be reported per patient at each time point. | Week 2 Visit | 
| Number of feeding tube complications for each patient with a study accessory | Minor complications associated with feeding tubes as defined by clinical assessment of treating physician at month 3. Total number of new complications will be reported per patient at each time point. | Month 3 Visit | 
| Number of feeding tube complications for each patient with a study accessory | Minor complications associated with feeding tubes as defined by clinical assessment of treating physician at early termination. Total number of new complications will be reported per patient at each time point. | Early termination (during the first 6 months) | 
| Number of feeding tube complications for each patient with a study accessory | Minor complications associated with feeding tubes as defined by clinical assessment of treating physician at month 6. Total number of new complications will be reported per patient at each time point. | Month 6 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 questionnaire | Using the PROMIS 10 questionnaire we will measure change using the physical and mental health global T scores for patient quality of life after intervention as self-reported by participants. Physical T score ranges 16.2 as the lowest to 67.7 as the highest and mental T score ranges from 21.2 to 67.6. A higher score at month 6 is indication of improvement. | Baseline | 
| Quality of Life PROMIS 10 questionnaire | Using the PROMIS 10 questionnaire we will measure change using the global physical and global mental health T scores for patient quality of life after intervention as self-reported by participants. Physical T score ranges 16.2 as the lowest to 67.7 as the highest and mental T score ranges from 21.2 to 67.6. A higher score at termination is indication of improvement. | Early termination (during the first 6 months) | 
| Quality of Life PROMIS 10 questionnaire | Using the PROMIS 10 questionnaire we will measure change using the global physical and global mental health T scores for patient quality of life after intervention as self-reported by participants. Physical T score ranges 16.2 as the lowest to 67.7 as the highest and mental T score ranges from 21.2 to 67.6. A higher score at month 6 is indication of improvement. | Month 6 Visit | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at baseline. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Baseline | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at week 2. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Week 2 Visit | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at week 4. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Week 4 Phone Call | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at week 6. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Week 6 Phone Call | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at early termination. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Early Termination (during the first 6 months) | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at month 3. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Month 3 Visit | 
| Characteristics of Pain and Leakage Questionnaire | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at month 4. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Month 4 Visit | 
| Characteristics of Pain and Leakage | Using a novel Characteristics of Pain and Leakage questionnaire with 4 unique quality of life questions, investigators will collect patient self reported data at month 6. Each question will have a score from one to 5 and the scores will be summed to a total score. A higher score corresponds to a higher quality of life. | Month 6 Visit |