Status:
TERMINATED
Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.
Lead Sponsor:
Rockfield Medical Devices
Collaborating Sponsors:
Horizon 2020 - European Commission
Conditions:
Enteral Feeding
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06173063
Start Date
November 14 2023
End Date
November 6 2024
Last Update
December 29 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905