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Placement of stoma site enteral feeding tube accessory for Feeding Tube Complication (SSA Trial)
SSA Trial Summary
This trial is to study a new accessory to prevent abdominal wall leakage for patients with a long term feeding tube. The accessory will be used for the first time in human subjects and will be used according to the manufacturer's instructions.
SSA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SSA Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Do seniors qualify for the study protocol?
"The minimum age for participation in this study is 22 years old, whereas the maximum age requirement is 85."
Is the recruitment phase of this project still active?
"Affirmative. Per clinicaltrials.gov, this medical research is actively enrolling participants since its posting on April 22nd 2022 and most recently updated on May 5th 2022. The study requires 10 patients from one site to join the trial."
What is the primary purpose of this clinical trial?
"The primary end goal of this trial, to be evaluated upon completion at Month 6 Visit, is to determine the number of feeding tube complications in each patient with a study accessory. Secondary outcomes include Characteristics of Pain and Leakage assessed by a novel questionnaire comprising 4 unique quality-of-life questions; Quality of Life Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Questionnaire which will measure changes through physical & mental health global T scores as self-reported by participants; and lastly Quality of Life PROMIS 10Questionnaire which evaluates improvements via Physical & Mental Health Global T Scores also reported by patients"
How many test subjects have been participating in this experiment?
"Affirmative, this investigation is actively seeking volunteers. According to the clinicaltrials.gov website, it was initially listed on April 22nd 2022 and has since been amended in May 5th 2022. The study needs 10 people from a single site for enrolment purposes."
What type of individuals is this experiment suitable for?
"The current clinical trial has a requirement that participants have to be between 22 and 85 years old. Potential test subjects must also meet additional criteria such as the capacity to comprehend written information, consenting to replace their existing gastrostomy/jejunostomy-inserted enteral feeding tube after 3 months, being willing to adhere and comply with study procedures for 6 months at least, agreeing on taking oral temperature measurements during specified times, etc. There are 10 slots available in total."
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