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

Enteral Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06173063
• Other study ID #: CLP001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Rockfield Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Device:
• Mobility+ Enteral Feeding System
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Rockfield Medical Devices	Horizon 2020 - European Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of enteral feed consumer per day	Volume in mls of enteral feed consumed in total, and with Mobility+	21 days
Secondary	Patient perspective on mobility using current enteral feeding system and Mobility+	Subjective scale (Likert) from Very Difficult to Very Easy on mobility performing common lifestyle activities	21 days
Secondary	Patient perspective on ease of use using current enteral feeding system and Mobility+	Subjective scale (Likert) from Strongly Disagree to Strongly Agree on the ease of use	21 days
Secondary	Patient perspective on feeding intolerance symptoms experienced using current enteral feeding system and Mobility+	Experience with common enteral feeding intolerance symptoms on a Likert scale from Mild to Severe	21 days
Secondary	Changes in participant Quality of Life	Subjective scale (Likert) from Excellent to Very Bad on patient's overall perspective from beginning to end of study	21 days
Secondary	Usability of Mobility+	Estimate if participants consume similar average volume (and kcals) of feed/day during the study, compared to baseline	21 days