Trial Outcomes & Findings for Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory (NCT NCT05288556)

Results Overview

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."

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Week 2 Visit

Results posted on

2025-07-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stoma Site Accessory n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2 Visit

Population: Four of five participants successfully completed the stoma accessory placement procedure.

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."

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Successful Accessory Placement	4 Participants

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Successful Accessory Placement	3 Participants

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Successful Accessory Placement	3 Participants

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Successful Accessory Placement	2 Participants

PRIMARY outcome

Timeframe: 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.

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."

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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."

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Population: No complications at 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.

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=5 Participants 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.
Number of Participants With a Feeding Tube Complication With a Study Accessory	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=5 Participants 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.
Number of Participants With a Feeding Tube Complication With a Study Accessory	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=5 Participants 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.
Number of Participants With a Feeding Tube Complication With a Study Accessory	1 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Four of five participants completed the baseline PROMIS10 survey

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.

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire Mental Health	45.125 T Score Standard Deviation 6.774646362
Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire Physical Health	44.075 T Score Standard Deviation 5.999097154

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=3 Participants 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.
Quality of Life PROMIS 10 Questionnaire Physical Health	45.6 T Score Standard Deviation 3.00499584
Quality of Life PROMIS 10 Questionnaire Mental Health	43.5 T Score Standard Deviation 4.582575695

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Four of five participants completed this measure

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=4 Participants 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.
Characteristics of Pain and Leakage	10.25 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 2 Visit

Population: Three of four participants completed this measure

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=3 Participants 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.
Characteristics of Pain and Leakage	12.33333333 score on a scale Standard Deviation 4.618802154

SECONDARY outcome

Timeframe: Week 4 Phone Call

Population: Three of five patients completed this measure

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=3 Participants 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.
Characteristics of Pain and Leakage	16 score on a scale Standard Deviation 4.041451884

SECONDARY outcome

Timeframe: Week 6 Phone Call

Population: Three of five participants completed this measure

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=3 Participants 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.
Characteristics of Pain and Leakage	11.66666667 score on a scale Standard Deviation 5.131601439

SECONDARY outcome

Timeframe: Month 3 Visit

Population: Two of five participants completed this measure

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=2 Participants 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.
Characteristics of Pain and Leakage	16 score on a scale Standard Deviation 1.414213562

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Stoma Site Accessory n=3 Participants 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.
Characteristics of Pain and Leakage	14.66666667 score on a scale Standard Deviation 0.577350269

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6 Visit

Population: No participants completed month 6 outcomes measures.

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.

Outcome measures

Outcome data not reported

Adverse Events

Stoma Site Accessory

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stoma Site Accessory n=5 participants at risk 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.
Blood and lymphatic system disorders Hospitalization	20.0% 1/5 • Number of events 1 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.
General disorders Hospitalization	20.0% 1/5 • Number of events 1 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.

Other adverse events

Other adverse events
Measure	Stoma Site Accessory n=5 participants at risk 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.
Nervous system disorders Inadvertent removal of tubing prior to month 6	20.0% 1/5 • Number of events 1 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.
Social circumstances Inadvertent removal of tubing prior to month 6	20.0% 1/5 • Number of events 1 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.
Surgical and medical procedures Surgical removal of embedded accessory prior to month 6	20.0% 1/5 • Number of events 1 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.
Product Issues Increased leakage due to migrating bumper	60.0% 3/5 • Number of events 3 • 6 months If the Principal Investigator, or his/her designee concludes the study accessory is malfunctioning, inadvertently removed or compromised or, for any reason, determined to be a greater risk than benefit, e.g., the patient has an allergic reaction, and is replaced by a commercially available accessory, the patient will be exited from the study by early termination.

Additional Information

Eric Yudelevich Blumrosen, MD

Cleveland Clinic

Phone: 216 445-6914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place