Status:
TERMINATED
A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes
Lead Sponsor:
Ohio State University
Conditions:
Long Term Enteral Tube Feeding
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 I...
Detailed Description
Gastrostomy tubes are enteral feeding devices that are designed to provide delivery of nutrients, fluids, medications directly into the stomach, bypassing the mouth and esophagus. These devices are al...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04030871
Start Date
October 25 2019
End Date
December 30 2023
Last Update
August 22 2025
Active Locations (1)
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1
Endoscopy Doan
Columbus, Ohio, United States, 43212