Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.

Rockfield Medical Devices1 site in 1 country19 target enrollmentNovember 14, 2023

ConditionsEnteral Feeding

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Enteral Feeding
Sponsor: Rockfield Medical Devices
Enrollment: 19
Locations: 1
Primary Endpoint: Volume of Enteral Feed Consumed Per Day
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this interventional study is to obtain information on the safety and effectiveness of a novel enteral feeding system in adult users requiring at least a portion of their nutritional intake via enteral feeding. The main questions it aims to answer are:

Can the device be used safely and effectively?
Does use of the device impact on patient's quality of life?

Participants will use Mobility+ enteral feeding system as their enteral feeding method for the duration of the study and will record their experiences.

Detailed Description

The study will allow 25 participants to use the Mobility+ system for their feeding sessions over the course of 14 consecutive days, following an initial 7-day period where participants have time to trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.

Registry

clinicaltrials.gov

Start Date

November 14, 2023

End Date

November 6, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rockfield Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants with Gastrostomy (G) tube or Jejunostomy (J) tubes
•Participant must require enteral tube feeding every day, as determined at the time of study enrolment
•Participant must use commercially available enteral formula with standard enteral feeding system(s) (gravity bag, bolus, pump or combination(s)), for some or all of their tube feeds, for daytime or day and night-time feeding
•Participant must be EN dependent i.e., 500 ml minimum daily feed intake from EN
•Participants must be able to swap from current system to Mobility+ for a minimum of two daily feeds per day for duration of study (Study days 1 -14)
•Participant must be \>= 18 to reflect the subset of the intended use population being evaluated
•Participant must be willing to participate in the study and provide consent).
•Participants must have been on an enteral feeding regime for a minimum of 10 weeks
•Participants clinical functional capacity is adequate as determined by operator clinical judgement, to enable them to participate fully in the study
•Participants are suitable candidates for using Mobility+ as determined by operator clinical judgement on participant enteral feeding needs (as per prescription) and alignment with Mobility+ Flow Rate Guide

Exclusion Criteria

•Participants who do not use commercially available enteral formula for some or all their formula needs
•Participants unable/unwilling to provide consent
•Participants whose enteral feeding needs do not match the offering of the Mobility+, as determined by operator clinical judgement
•Participants who have inadequate clinical functional capacity, as determined by operator clinical judgement to participate fully in the study e.g. neuromuscular or neurodegenerative disorders, or developmental delay
•Participants with very limited mobility, as determined by operator clinical opinion

Outcomes

Primary Outcomes

Volume of Enteral Feed Consumed Per Day

Time Frame: 14 days

Volume in mls of enteral feed consumed in total, and with Mobility+

Secondary Outcomes

Usability of Mobility+ (Volume)(14 days)
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+(14 days)
Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+(14 days)
Participant Perspective on Quality of Life(14 days)
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+(14 days)
Usability of Mobility+ (kcal)(14 days)