A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes
Stopped early · Not applicable
Conditions studied: Long Term Enteral Tube Feeding
In brief
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
Key facts
- Study ID
- NCT04030871
- Run by
- Ohio State University
- People needed
- 7
- Starts
- 2019-10-25
- Expected to finish
- 2023-12-30
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Expected to survive 12 months. Exclusion Criteria
- The following subjects will not be eligible for inclusion in the study:
- 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.
- Impaired cognition, inability to provide assessment feedback by telephone.
- Subjects not expected to survive > 12 months
Where it is running
- Endoscopy Doan — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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