A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feed… (NCT04030871) | Clinical Trial Compass
TerminatedNot Applicable
A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes
Stopped: Inability to recruit study participants
United States7 participantsStarted 2019-10-25
Plain-language summary
This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization ICHE6, R2), the Code of Federal Regulations Title 21 parts 803 and 812, and other applicable government regulations and Institutional research policies and procedures. The purpose of the study is to compare the cost effectiveness and tolerability of standard of care gastrostomy tubes to newer capsule dome gastrostomy tubes. The newer tubes are significantly more expensive, therefore the aims of this study will be to determine economic feasibility of going to the new model. Data are lacking on the newer g-tubes in terms of longevity and cost-effectiveness
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed an IRB-approved informed consent form for the study.
✓. Adults (18-75 years of age)
✓. Requirement of long term enteral tube feeding (\> to 12 months) and are due for a change of their initial or prior replacement bolus Percutaneous Endoscopic Gastrostomy (PEG) tube.
✓. Ability to consent for the procedure and study.
✓. Subjects must be able to communicate in english via telephone and understand the assessment checklists.
Exclusion criteria
✕. Enteral feeding is not necessary for at least 12 months,
✕. A medical condition that makes it impossible for them to communicate via telephone
✕. Subjects requiring feeding into the jejunum via a combined gastroenterostomy-jejunostomy tube
✕. Subjects who require endoscopic replacement of their current gastrostomy tube.