Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
NCT ID: NCT05288556
Last Updated: 2025-07-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
5 participants
INTERVENTIONAL
2022-04-22
2023-09-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
NCT03549780
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
NCT02890875
A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
NCT04845906
Innovative Central Line Securement Device in the Pediatric Population
NCT04522778
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
NCT01246505
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stoma Site Accessory
Stoma site accessory with enteral tube replacement procedure.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
22 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eric Yudelevich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eric Yudelevich
Eric Yudelevich, MD Assistant Professor, Director of Clinical Competency Development
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric Yudelevich, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-143
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.