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NCT06173063

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

Terminated NA Results posted Last updated 29 December 2025
What this trial tests

NA trial testing Mobility+ Enteral Feeding System in Enteral Feeding in 19 participants. Terminated before completion.

Timeline
14 November 2023
Primary endpoint
6 November 2024
6 November 2024

Quick facts

Lead sponsorRockfield Medical Devices
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment19
Start date14 November 2023
Primary completion6 November 2024
Estimated completion6 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rockfield Medical Devices

Who can join

18 and older, any sex, with Enteral Feeding. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Volume of Enteral Feed Consumed Per Day Primary · 14 days

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

Volume in milliliters of enteral feed consumed (Mobility+)
GroupValue95% CI
Patient Cohort1050± 363
Volume in milliliters of enteral feed consumed (other EN systems)
GroupValue95% CI
Patient Cohort256± 294
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ Secondary · 14 days

Subjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1).

Moving from one room to another (Baseline)
GroupValue95% CI
Patient Cohort2.6± 1.2
Moving from one room to another (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort4.6± 0.5
Going up and down stairs (Baseline)
GroupValue95% CI
Patient Cohort2.1± 1.3
Going up and down stairs (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort4.6± 0.5
Short walk (e.g 1 block) (Baseline)
GroupValue95% CI
Patient Cohort2.3± 1.2
Short walk (e.g. 1 block) (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort4.5± 0.6
Long walk (e.g. several blocks) (Baseline)
GroupValue95% CI
Patient Cohort1.9± 1.1
Long walk (e.g. several blocks) (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort4.4± 0.7
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ Secondary · 14 days

Subjective scale (Likert) - Ease of use of current enteral feeding systems and Mobility+ were rated as: Strongly agree (5), Somewhat agree (4), Neutral (3), Somewhat disagree (2), Strongly disagree (1).

System is easy to use (Baseline)
GroupValue95% CI
Patient Corhort3.8± 0.8
System is easy to use (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Corhort3.5± 1.5
System is easy to carry (Baseline)
GroupValue95% CI
Patient Corhort2.8± 1.4
System is easy to carry (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Corhort4.2± 1.0
The noise level of system is acceptable (Baseline)
GroupValue95% CI
Patient Corhort4.2± 1.2
The noise level of system is acceptable (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Corhort4.8± 0.5
System allows me to feed discreetly (Baseline)
GroupValue95% CI
Patient Corhort1.9± 1.2
System allows me to feed discreetly (End of Study post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Corhort3.6± 1.3
Participant Perspective on Quality of Life Secondary · 14 days

Subjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1)

Quality of life (participant perspective) at baseline
GroupValue95% CI
Patient Cohort3.6± 0.9
Quality of life (participant perspective) at end of Study, post 14 d feeding w/ Mobility+ (Day 21)
GroupValue95% CI
Patient Cohort3.7± 0.8
Usability of Mobility+ (Volume) Secondary · 14 days

Estimate if participants consume similar average volume of feed/day during the study, compared to baseline

Total enteral feed volume consumed per day at baseline
GroupValue95% CI
Patient Cohort1174± 353
Total enteral feed volume consumed per day at end of Study, post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort1306± 318
Total enteral feed kcal consumed per day, at baseline
GroupValue95% CI
Patient Cohort1848± 604
Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort2034± 527
Usability of Mobility+ (kcal) Secondary · 14 days

Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline

Total enteral feed kcal consumed per day, at baseline
GroupValue95% CI
Patient Cohort1848± 604
Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21))
GroupValue95% CI
Patient Cohort2034± 527

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Enteral Feeding

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06173063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing