Feeding Tube Complication
Conditions
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.
Interventions
DEVICEPlacement 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.
Sponsors
Eric Yudelevich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Site, Prospective, Phase I Study, Safety and Efficacy
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Accessory Placement | 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. |
| Number of Participants With a Feeding Tube Complication With a Study Accessory | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire | Baseline | 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. |
| Quality of Life PROMIS 10 Questionnaire | Early termination (during the first 6 months) | 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. |
| Characteristics of Pain and Leakage | Baseline | 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) |
| Characteristics of Pain and Leakage Questionnaire | Month 4 Visit | 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. |
Countries
United States
Participant flow
Recruitment details
Potential patients were recruited based on physician referrals at 2 of Cleveland Clinic's academic medical centers between 4/29/22 and 6/22/23. Of the 31 patients screened for eligibility, five patients were consented and scheduled for the study stoma accessory during a standard of care replacement procedure. Of these five, one retained the accessory into week six and two retained the accessory up to week 12 of the 24 week study period.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Stoma Site Accessory |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 3 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
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.
Time frame: Baseline
Population: No complications at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Number of Participants With a Feeding Tube Complication With a Study Accessory | 0 Participants |
Primary
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.
Time frame: Week 2 Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Number of Participants With a Feeding Tube Complication With a Study Accessory | 2 Participants |
Primary
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.
Time frame: Month 3 Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Number of Participants With a Feeding Tube Complication With a Study Accessory | 1 Participants |
Primary
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.
Time frame: Early termination (during the first 6 months)
Population: No participant reached the 6 month time point as described previously (and captured under Early Termination). 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.
Primary
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.
Time frame: Month 6 Visit
Population: No participant reached the 6 month time point as described previously (and captured under Early Termination). 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.
Primary
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.
Time frame: Month 3 Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Successful Accessory Placement | 2 Participants |
Primary
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.
Time frame: Month 6 Visit
Population: No participant reached the 6 month time point as described previously (and captured under Early Termination). 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.
Primary
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.
Time frame: Month 4 Visit
Population: No participant reached the 4 month mark, as described previously (and captured under Early Termination).~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.
Primary
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.
Time frame: Week 2 Visit
Population: Four of five participants successfully completed the stoma accessory placement procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Successful Accessory Placement | 4 Participants |
Primary
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.
Time frame: Week 4 Phone call
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Successful Accessory Placement | 3 Participants |
Primary
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.
Time frame: Week 6 Phone call
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stoma Site Accessory | Successful Accessory Placement | 3 Participants |
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. 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.
Time frame: Month 6 Visit
Population: No participants completed month 6 outcomes measures.
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Week 4 Phone Call
Population: Three of five patients completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 16 score on a scale | Standard Deviation 4.041451884 |
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Week 6 Phone Call
Population: Three of five participants completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 11.66666667 score on a scale | Standard Deviation 5.131601439 |
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Month 3 Visit
Population: Two of five participants completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 16 score on a scale | Standard Deviation 1.414213562 |
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Early Termination (during the first 6 months)
Population: Participants were asked to complete the Characteristics of Pain and Leakage at early termination whenever it occurred prior to month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 14.66666667 score on a scale | Standard Deviation 0.577350269 |
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Baseline
Population: Four of five participants completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 10.25 score on a scale | Standard Deviation 2.5 |
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 (with a total score of 4 representing lowest quality of life, and a score of 20 representing the highest quality of life)
Time frame: Week 2 Visit
Population: Three of four participants completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stoma Site Accessory | Characteristics of Pain and Leakage | 12.33333333 score on a scale | Standard Deviation 4.618802154 |
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 (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.
Time frame: Month 4 Visit
Population: 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.
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.
Time frame: Baseline
Population: Four of five participants completed the baseline PROMIS10 survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stoma Site Accessory | Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire | Mental Health | 45.125 T Score | Standard Deviation 6.774646362 |
| Stoma Site Accessory | Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire | Physical Health | 44.075 T Score | Standard Deviation 5.999097154 |
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.
Time frame: Early termination (during the first 6 months)
Population: Participants were asked to complete the PROMIS 10 at early termination whenever it occurred prior to month 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stoma Site Accessory | Quality of Life PROMIS 10 Questionnaire | Physical Health | 45.6 T Score | Standard Deviation 3.00499584 |
| Stoma Site Accessory | Quality of Life PROMIS 10 Questionnaire | Mental Health | 43.5 T Score | Standard Deviation 4.582575695 |
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 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.
Time frame: Month 6 Visit
Population: No patient reached the 6 month time point. No participant reached the 6 month time point as described previously (and captured under Early Termination). 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.