Clinical trial NCT06173063: Safety and Effectiveness of a Novel Enteral Feeding System: Prospective Study.
Official title: Safety and Effectiveness of a Novel Enteral Feeding System: Prospective Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Enteral Feeding
Keywords: Enteral Feeding
Mobility
Quality of Life
Elastomeric
Lead sponsor: Rockfield Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Horizon 2020 - European Commission
First posted: 2023-12-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 25 adult subjects from a screening population of 200
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Volume of enteral feed consumer per day
timeFrame: 21 days
Secondary outcomes:
measure: Patient perspective on mobility using current enteral feeding system and Mobility+
timeFrame: 21 days
measure: Patient perspective on ease of use using current enteral feeding system and Mobility+
timeFrame: 21 days
measure: Patient perspective on feeding intolerance symptoms experienced using current enteral feeding system and Mobility+
timeFrame: 21 days
measure: Changes in participant Quality of Life
timeFrame: 21 days
measure: Usability of Mobility+
timeFrame: 21 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet Mundi
role: PRINCIPAL_INVESTIGATOR
References: