Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

NCT05288556 | Terminated Results DMC FDA Device

• 1 other identifier: 21-143
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Tube Complication

Outcome Measures

Primary Outcomes (11)

• Successful Accessory Placement

  Using the accessory placement date as the baseline, the number of participants 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 number of participants 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 number of participants 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 number of participants 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 number of participants 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 number of participants 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 Participants With a Feeding Tube Complication 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 Participants With a Feeding Tube Complication 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 Participants With a Feeding Tube Complication 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 Participants With a Feeding Tube Complication 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 Participants With a Feeding Tube Complication 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 Outcomes (11)

• Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire

  Baseline

• Quality of Life PROMIS 10 Questionnaire

  Early termination (during the first 6 months)

• Quality of Life PROMIS 10 Questionnaire

  Month 6 Visit

• Characteristics of Pain and Leakage

  Baseline

• Characteristics of Pain and Leakage

  Week 2 Visit

Study Arms (1)

Stoma Site Accessory

EXPERIMENTAL

Stoma site accessory with enteral tube replacement procedure.

Device: Placement of stoma site enteral feeding tube accessory

Interventions

Placement of stoma site enteral feeding tube accessory DEVICE

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.

Stoma Site Accessory

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eric Yudelevich: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (10)

• 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.

  PMID: 16306298 BACKGROUND

• 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.

  PMID: 20541746 BACKGROUND

• 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.

  PMID: 31006929 BACKGROUND

• 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.

  PMID: 31528280 BACKGROUND

• 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.

  PMID: 18679534 BACKGROUND

• 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.

  PMID: 25024606 BACKGROUND

• 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.

  PMID: 30081546 BACKGROUND

• 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.

  PMID: 28715295 BACKGROUND

• 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.

  PMID: 31083338 BACKGROUND

• 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.

  PMID: 25606646 BACKGROUND

Results Point of Contact

• Title: Eric Yudelevich Blumrosen, MD
• Organization: Cleveland Clinic

YUDELEE@ccf.org

216 445-6914

Study Officials

• Eric Yudelevich, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Eric Yudelevich, MD Assistant Professor, Director of Clinical Competency Development

Model Details: Single Site, Prospective, Phase I Study, Safety and Efficacy

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 21, 2022
• Study Start: April 22, 2022
• Primary Completion: June 22, 2023
• Study Completion: September 11, 2023
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)