Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

Feeding Tube Complication Clinical Trial

— SSA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05288556
• Other study ID #: 21-143
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding Tube Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eric Yudelevich

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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