Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.
NCT ID: NCT06173063
Last Updated: 2025-12-29
Study Results
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View full resultsBasic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2023-11-14
2024-11-06
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Mobility+ Arm
Adult patients using Mobility+ novel enteral feeding system for nutritional intake.
Mobility+ Enteral Feeding System
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.
Interventions
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Mobility+ Enteral Feeding System
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Horizon 2020 - European Commission
OTHER
Rockfield Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Manpreet Mundi
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLP001
Identifier Type: -
Identifier Source: org_study_id