Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory (SSA)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Feeding Tube Complication
• Intervention / Treatment: Device: Placement of stoma site enteral feeding tube accessory

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Yudelevich, MD; Phone Number: 216 445-6914; Email: Yudelee@ccf.org
• Study Contact Backup: Name: Linda Libertini, CRC; Phone Number: 216 4488339; Email: Libertl@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stoma Site Accessory; Stoma site accessory with enteral tube replacement procedure.

Device: Placement of stoma site enteral feeding tube accessory; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eric Yudelevich
• Investigators: Principal Investigator: Eric Yudelevich, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• DeLegge RL, DeLegge MH. Percutaneous endoscopic gastrostomy evaluation of device materials: are we "failsafe"? Nutr Clin Pract. 2005 Dec;20(6):613-7. doi: 10.1177/0115426505020006613.
• Green SM, Townsend K, Jarrett N, Fader M. The experiences and support needs of people living at home with an enteral tube: a qualitative interview study. J Hum Nutr Diet. 2019 Oct;32(5):646-658. doi: 10.1111/jhn.12656. Epub 2019 Apr 21.
• Malik F, Baig SN, Patel B, Gonzalez M, Nfonoyim J. Unusual complication of a percutaneous gastrostomy tube. J Community Hosp Intern Med Perspect. 2019 Sep 5;9(4):325-326. doi: 10.1080/20009666.2019.1650410. eCollection 2019.
• Potack JZ, Chokhavatia S. Complications of and controversies associated with percutaneous endoscopic gastrostomy: report of a case and literature review. Medscape J Med. 2008 Jun 17;10(6):142.
• Blumenstein I, Shastri YM, Stein J. Gastroenteric tube feeding: techniques, problems and solutions. World J Gastroenterol. 2014 Jul 14;20(26):8505-24. doi: 10.3748/wjg.v20.i26.8505.
• Gramlich L, Hurt RT, Jin J, Mundi MS. Home Enteral Nutrition: Towards a Standard of Care. Nutrients. 2018 Aug 4;10(8):1020. doi: 10.3390/nu10081020.
• Mundi MS, Pattinson A, McMahon MT, Davidson J, Hurt RT. Prevalence of Home Parenteral and Enteral Nutrition in the United States. Nutr Clin Pract. 2017 Dec;32(6):799-805. doi: 10.1177/0884533617718472. Epub 2017 Jul 17.
• Ojo O, Keaveney E, Wang XH, Feng P. The Effect of Enteral Tube Feeding on Patients' Health-Related Quality of Life: A Systematic Review. Nutrients. 2019 May 10;11(5):1046. doi: 10.3390/nu11051046.
• Hall BT, Englehart MS, Blaseg K, Wessel K, Stawicki SP, Evans DC. Implementation of a dietitian-led enteral nutrition support clinic results in quality improvement, reduced readmissions, and cost savings. Nutr Clin Pract. 2014 Oct;29(5):649-55. doi: 10.1177/0884533614538285.
• ASGE Technology Committee; Kwon RS, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Mamula P, Pedrosa MC, Rodriguez SA, Varadarajulu S, Song LM, Tierney WM. Enteral nutrition access devices. Gastrointest Endosc. 2010 Aug;72(2):236-48. doi: 10.1016/j.gie.2010.02.008. Epub 2010 Jun 11.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No