NCT04030871

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

A Single-Center, Investigator-Initiated, Randomized, Pilot Study Comparing Cost Effectiveness Two Commercially Available Gastric Feeding Tubes (Capsule Dome G-Tube Versus Balloon Bolus Feeding Tube).

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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 also known as gastrostomy tubes (G-tubes) or percutaneous endoscopic gastrostomy tube (PEG tube). These are used when patients have conditions that make them unable to swallow. While parenteral (Intravenous) nutrition and nasogastric tubes are also nutritional-support methods. A variety of g-tube designs have been used in pediatric to adult populations. The insertion of a g-tube is one of the most common endoscopic procedures and is relatively safe. The OSU endoscopy lab placed 381 g-tubes in 2018. The most common G-tube used by the OSU Endoscopy Lab is the Balloon Bolus feeding tube. In 2017 the Capsule Dome G-Tube became commercially available. The cost of the Capsule dome g-tube is twice as expensive as the standard balloon g-tube. The insertion costs would be comparable. The need to perform a pilot comparative study of the two g-tubes is necessary to improve our physicians understanding of the potential cost-effectiveness that longer patency we could gather from the alternative device.

Conditions

• Long Term Enteral Tube Feeding

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-25
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2019-07-24
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States