Feeding Tube ComplicationSSANCT05288556
Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
A study testing Placement of stoma site enteral feeding tube accessory in people with Feeding Tube Complication, run by Eric Yudelevich at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Feeding Tube Complication
- What is being tested?
- Placement of stoma site enteral feeding tube accessory
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 11 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Feeding Tube Complication
- Being tested
- Placement of stoma site enteral feeding tube accessory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of stoma site enteral feeding tube accessoryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Stoma Site Accessory | Experimental | Stoma site accessory with enteral tube replacement procedure. Receives: Device: Placement of stoma site enteral feeding tube accessory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6 Visit
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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 at the 6 month time point, as self-reported by participants. No specific threshold is used. 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.
No participant reached the 6 month mark, as described previously (and captured under Early Termination). Therefore, there are 0 PROMIS 10 scores to report.
Outcome Measures is reported with zero total participants analyzed, because the study was terminated and data collection stopped prior to the pre-specified time points/end points for an outcome.
Measured: 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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: 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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: 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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: 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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: 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 month 3.
Each question will have a score from one to 5 and the scores will be summed to a total score (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: Month 3 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 early termination.
Each question will have a score from one to 5 and the scores will be summed to a total score (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Measured: Early Termination (during the first 6 months)
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
No participant reached the 4 month mark, as described previously (and captured under Early Termination). Therefore, there are 0 Characteristics of Pain and Leakage Questionnaire scores to report.
Outcome Measures is reported with zero total participants analyzed, because the study was terminated and data collection stopped prior to the pre-specified time points/end points for an outcome.
Measured: 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.
No participant reached the 6 month mark, as described previously (and captured under Early Termination). Therefore, there are 0 Characteristics of Pain and Leakage Questionnaire scores to report. Please see the completed questionnaires captured by Early Termination on Outcome Measure #20.
Outcome Measures is reported with zero total participants analyzed, because the study was terminated and data collection stopped prior to the pre-specified time points/end points for an outcome.
Measured: Month 6 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start22 Apr 2022
- Primary completion22 Jun 2023
- Study completion11 Sep 2023
Why it stopped: Voluntary pause in enrollment to revise inclusion criteria and need for reliable transportation, after one unanticipated problem with a participant who had challenges attending safety clinical visits.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Feeding Tube ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Site, Prospective, Phase I Study, Safety and Efficacy
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Yudelevich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Yudelevich, The Cleveland Clinic
- Investigators
- Eric Yudelevich, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288556
- Sponsor's protocol ID
- 21-143
- Acronym
- SSA
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2022
- Last updated
- 25 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 16306298ASGE 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.
PubMed 20541746Green 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.
PubMed 31006929Malik 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.
PubMed 31528280Potack 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.
PubMed 18679534Blumenstein 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.
PubMed 25024606Gramlich 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.
PubMed 30081546Mundi 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.
PubMed 28715295Ojo 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.
PubMed 31083338Hall 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.
PubMed 25606646
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
- ClinicalTrials.gov ID
- NCT05288556
- Acronym / sponsor ID
- SSA / 21-143
- Conditions
- Feeding Tube Complication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntary pause in enrollment to revise inclusion criteria and need for reliable transportation, after one unanticipated problem with a participant who had challenges attending safety clinical visits.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eric YudelevichUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Posted 25 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Site, Prospective, Phase I Study, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Stoma Site Accessory | Experimental | Device: Placement of stoma site enteral feeding tube accessoryStoma site accessory with enteral tube replacement procedure. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of stoma site enteral feeding tube accessoryThe 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. | Device | Stoma Site Accessory |
Primary outcome
Successful Accessory Placement
Time frame: Week 2 Visit
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."
Successful Accessory Placement
Time frame: Week 4 Phone call
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."
Successful Accessory Placement
Time frame: Week 6 Phone call
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."
Successful Accessory Placement
Time frame: Month 3 Visit
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."
Successful Accessory Placement
Time frame: Month 4 Visit
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."
Successful Accessory Placement
Time frame: Month 6 Visit
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."
Number of Participants With a Feeding Tube Complication With a Study Accessory
Time frame: Baseline
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.
Number of Participants With a Feeding Tube Complication With a Study Accessory
Time frame: Week 2 Visit
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.
Number of Participants With a Feeding Tube Complication With a Study Accessory
Time frame: Month 3 Visit
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.
Number of Participants With a Feeding Tube Complication With a Study Accessory
Time frame: Early termination (during the first 6 months)
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.
Number of Participants With a Feeding Tube Complication With a Study Accessory
Time frame: Month 6 Visit
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.
11 secondary outcomes
Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire
Time frame: Baseline
Quality of Life PROMIS 10 Questionnaire
Time frame: Early termination (during the first 6 months)
Quality of Life PROMIS 10 Questionnaire
Time frame: Month 6 Visit
Characteristics of Pain and Leakage
Time frame: Baseline
Characteristics of Pain and Leakage
Time frame: Week 2 Visit
Characteristics of Pain and Leakage
Time frame: Week 4 Phone Call
Characteristics of Pain and Leakage
Time frame: Week 6 Phone Call
Characteristics of Pain and Leakage
Time frame: Month 3 Visit
Characteristics of Pain and Leakage
Time frame: Early Termination (during the first 6 months)
Characteristics of Pain and Leakage Questionnaire
Time frame: Month 4 Visit
Characteristics of Pain and Leakage
Time frame: Month 6 Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16306298DeLegge 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.
- Background: PubMed 20541746ASGE 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.
- Background: PubMed 31006929Green 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.
- Background: PubMed 31528280Malik 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.
- Background: PubMed 18679534Potack 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.
- Background: PubMed 25024606Blumenstein 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.
- Background: PubMed 30081546Gramlich 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Yudelevich, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of stoma site enteral feeding tube accessory in people with Feeding Tube Complication, run by Eric Yudelevich at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Accessory Placement (time frame: Week 2 Visit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288556, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.