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

Rockfield Medical Devices

Status

Terminated

Conditions

Enteral Feeding

Treatments

Device: Mobility+ Enteral Feeding System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06173063

CLP001

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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