Single Site, Prospective, Phase I Study, Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Successful Accessory Placement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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
结局指标
主要结局
Successful Accessory Placement
时间窗: 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
时间窗: 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.
Successful Accessory Placement
时间窗: 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
时间窗: 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.
次要结局
- Characteristics of Pain and Leakage Questionnaire(Month 4 Visit)
- Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire(Baseline)
- Quality of Life PROMIS 10 Questionnaire(Month 6 Visit)
- Characteristics of Pain and Leakage(Month 6 Visit)
- Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire(Baseline)
- Quality of Life PROMIS 10 Questionnaire(Month 6 Visit)
- Characteristics of Pain and Leakage(Month 6 Visit)
- Characteristics of Pain and Leakage Questionnaire(Month 4 Visit)
研究者
Eric Yudelevich
Eric Yudelevich, MD Assistant Professor, Director of Clinical Competency Development
The Cleveland Clinic