Clinical trial NCT05288556: Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
Official title: Single Site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Feeding Tube Complication
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Site, Prospective, Phase I Study, Safety and Efficacy
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Accessory placement
timeFrame: Week 2 Visit
measure: Successful Accessory placement
timeFrame: Week 4 Phone call
measure: Successful Accessory placement
timeFrame: Week 6 Phone call
measure: Successful Accessory placement
timeFrame: Month 3 Visit
measure: Successful Accessory placement
timeFrame: Month 4 Visit
measure: Successful Accessory placement
timeFrame: Month 6 Visit
measure: Number of feeding tube complications for each patient with a study accessory
timeFrame: Baseline
measure: Number of feeding tube complications for each patient with a study accessory
timeFrame: Week 2 Visit
measure: Number of feeding tube complications for each patient with a study accessory
timeFrame: Month 3 Visit
measure: Number of feeding tube complications for each patient with a study accessory
timeFrame: Early termination (during the first 6 months)
measure: Number of feeding tube complications for each patient with a study accessory
timeFrame: Month 6 Visit
Secondary outcomes:
measure: Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 questionnaire
timeFrame: Baseline
measure: Quality of Life PROMIS 10 questionnaire
timeFrame: Early termination (during the first 6 months)
measure: Quality of Life PROMIS 10 questionnaire
timeFrame: Month 6 Visit
measure: Characteristics of Pain and Leakage
timeFrame: Baseline
measure: Characteristics of Pain and Leakage
timeFrame: Week 2 Visit
measure: Characteristics of Pain and Leakage
timeFrame: Week 4 Phone Call
measure: Characteristics of Pain and Leakage
timeFrame: Week 6 Phone Call
measure: Characteristics of Pain and Leakage
timeFrame: Early Termination (during the first 6 months)
measure: Characteristics of Pain and Leakage
timeFrame: Month 3 Visit
measure: Characteristics of Pain and Leakage Questionnaire
timeFrame: Month 4 Visit
measure: Characteristics of Pain and Leakage
timeFrame: Month 6 Visit
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Eric Yudelevich, MD
role: PRINCIPAL_INVESTIGATOR
References:
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