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

NCT06173063 | Terminated Results FDA Device

• 1 other identifier: CLP001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding

Keywords

Enteral Feeding; Mobility; Quality of Life; Elastomeric

Outcome Measures

Primary Outcomes (1)

• Volume of Enteral Feed Consumed Per Day

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

  14 days

Secondary Outcomes (6)

• Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+

  14 days

• Patient Perspective on Ease of Use Using Current Enteral Feeding System and 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

• Usability of Mobility+ (Volume)

  14 days

Study Arms (1)

Mobility+ Arm

EXPERIMENTAL

Adult patients using Mobility+ novel enteral feeding system for nutritional intake.

Device: Mobility+ Enteral Feeding System

Interventions

Mobility+ Enteral Feeding System DEVICE

Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.

Also known as: Mobility+, MOB

Mobility+ Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockfield Medical Devices: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Range of Motion, Articular

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Edel Keaveney, Senior Research Manager
• Organization: Rockfield Medical Devices Ltd.

edel@rockfieldmd.com

(+353) (0)91 763 000

Study Officials

• Manpreet Mundi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 25 adult subjects from a screening population of 200

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 15, 2023
• Study Start: November 14, 2023
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: December 29, 2025
• Results First Posted: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)