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A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes

NCT04030871 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-03-02

No results posted yet for this study

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

Conditions

  • Long Term Enteral Tube Feeding

Interventions

DEVICE

Capsule Dome G-Tube

Feeding replacement tubes with two different FDA approved devices in forty subjects

DEVICE

Balloon Bolus feeding tube

Feeding replacement tubes with two different FDA approved devices in forty subjects

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Jeffery R Groce, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030871 on ClinicalTrials.gov