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

December 7, 2023 updated by: Rockfield Medical Devices

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobility+ Arm
Adult patients using Mobility+ novel enteral feeding system for nutritional intake.
Device: Mobility+ Enteral Feeding System
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.
Other Names:
  • Mobility+
  • MOB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of enteral feed consumer per day
Time Frame: 21 days
Volume in mls of enteral feed consumed in total, and with Mobility+
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockfield Medical Devices

Collaborators

Horizon 2020 - European Commission

Investigators

  • Principal Investigator: Manpreet Mundi, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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