Trial Outcomes & Findings for Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study. (NCT NCT06173063)
NCT ID: NCT06173063
Last Updated: 2025-12-29
Results Overview
Volume in mls of enteral feed consumed in total, and with Mobility+
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
14 days
Results posted on
2025-12-29
Participant Flow
Participant milestones
| Measure |
Patient Cohort
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
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|---|---|
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Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Patient Cohort
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
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|---|---|
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Age, Continuous
|
63.8 Year
STANDARD_DEVIATION 12.0 • n=17 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=17 Participants
|
|
Weight
|
69.0 Kilogram
STANDARD_DEVIATION 15.0 • n=17 Participants
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|
Height
|
171.5 Centimetres
STANDARD_DEVIATION 9.5 • n=17 Participants
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Body Mass Index (BMI)
|
23.3 Kilogram per square metre
STANDARD_DEVIATION 3.4 • n=17 Participants
|
|
EN formula consumed
|
1174 milliliters per day
STANDARD_DEVIATION 353 • n=17 Participants
|
|
EN daily calories
|
1907 kcal per day
STANDARD_DEVIATION 553 • n=17 Participants
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|
Daily EN feeding sessions
|
2.9 Feeding sessions per day
STANDARD_DEVIATION 1.1 • n=17 Participants
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|
Total infusion time
|
3.0 hours per day
STANDARD_DEVIATION 3.5 • n=17 Participants
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PRIMARY outcome
Timeframe: 14 daysVolume in mls of enteral feed consumed in total, and with Mobility+
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
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|---|---|
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Volume of Enteral Feed Consumed Per Day
Volume in milliliters of enteral feed consumed (Mobility+)
|
1050 milliliters per day
Standard Deviation 363
|
|
Volume of Enteral Feed Consumed Per Day
Volume in milliliters of enteral feed consumed (other EN systems)
|
256 milliliters per day
Standard Deviation 294
|
SECONDARY outcome
Timeframe: 14 daysSubjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1).
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
|
|---|---|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Ability to sleep (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.8 Scores on a scale
Standard Deviation 1.1
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Socializing with friends/family (Baseline)
|
3.2 Scores on a scale
Standard Deviation 1.1
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Socializing with friends/family (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
4.3 Scores on a scale
Standard Deviation 0.8
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Moving from one room to another (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
4.6 Scores on a scale
Standard Deviation 0.5
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Going up and down stairs (Baseline)
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2.1 Scores on a scale
Standard Deviation 1.3
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Going up and down stairs (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
4.6 Scores on a scale
Standard Deviation 0.5
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Short walk (e.g 1 block) (Baseline)
|
2.3 Scores on a scale
Standard Deviation 1.2
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Short walk (e.g. 1 block) (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
4.5 Scores on a scale
Standard Deviation 0.6
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Long walk (e.g. several blocks) (Baseline)
|
1.9 Scores on a scale
Standard Deviation 1.1
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Long walk (e.g. several blocks) (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
4.4 Scores on a scale
Standard Deviation 0.7
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Travelling in car/public transport (Baseline)
|
2.4 Scores on a scale
Standard Deviation 1.2
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Travelling in car/public transport (End of Study post 14 d feeding w/ Mobility+ (Day 21)
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3.8 Scores on a scale
Standard Deviation 1.1
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Moderate intensity physical activities (Baseline)
|
1.8 Scores on a scale
Standard Deviation 1.1
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Moderate intensity physical activities (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.8 Scores on a scale
Standard Deviation 1.0
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Other daily activities (high intensity physical activities) (Baseline)
|
1.8 Scores on a scale
Standard Deviation 1.1
|
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Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Other daily high intensity physical activities(End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.7 Scores on a scale
Standard Deviation 0.9
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Moving from one room to another (Baseline)
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2.6 Scores on a scale
Standard Deviation 1.2
|
|
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Ability to sleep (Baseline)
|
2.9 Scores on a scale
Standard Deviation 1.5
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SECONDARY outcome
Timeframe: 14 daysSubjective 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).
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
|
|---|---|
|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System is easy to use (Baseline)
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3.8 Scores on a scale
Standard Deviation 0.8
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|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System is easy to use (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.5 Scores on a scale
Standard Deviation 1.5
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|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System is easy to carry (Baseline)
|
2.8 Scores on a scale
Standard Deviation 1.4
|
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Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System is easy to carry (End of Study post 14 d feeding w/ Mobility+ (Day 21))
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4.2 Scores on a scale
Standard Deviation 1.0
|
|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
The noise level of system is acceptable (Baseline)
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4.2 Scores on a scale
Standard Deviation 1.2
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Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
The noise level of system is acceptable (End of Study post 14 d feeding w/ Mobility+ (Day 21))
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4.8 Scores on a scale
Standard Deviation 0.5
|
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Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System allows me to feed discreetly (Baseline)
|
1.9 Scores on a scale
Standard Deviation 1.2
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|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
System allows me to feed discreetly (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.6 Scores on a scale
Standard Deviation 1.3
|
|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
I am satisfied with the overall performance of the system (Baseline)
|
3.5 Scores on a scale
Standard Deviation 1.2
|
|
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
I'm satisfied with overall system performance (End of Study post 14 d feeding w/ Mobility+ (Day 21))
|
3.6 Scores on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 14 daysPopulation: This data was not collected for operational reasons as it was considered over burdensome to ask participants these questions due to time pressures during study execution and the extent of questions already posed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysSubjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1)
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
|
|---|---|
|
Participant Perspective on Quality of Life
Quality of life (participant perspective) at baseline
|
3.6 Scores on a scale
Standard Deviation 0.9
|
|
Participant Perspective on Quality of Life
Quality of life (participant perspective) at end of Study, post 14 d feeding w/ Mobility+ (Day 21)
|
3.7 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 14 daysEstimate if participants consume similar average volume of feed/day during the study, compared to baseline
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
|
|---|---|
|
Usability of Mobility+ (Volume)
Total enteral feed volume consumed per day at baseline
|
1174 milliliters per day
Standard Deviation 353
|
|
Usability of Mobility+ (Volume)
Total enteral feed volume consumed per day at end of Study, post 14 d feeding w/ Mobility+ (Day 21))
|
1306 milliliters per day
Standard Deviation 318
|
|
Usability of Mobility+ (Volume)
Total enteral feed kcal consumed per day, at baseline
|
1848 milliliters per day
Standard Deviation 604
|
|
Usability of Mobility+ (Volume)
Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21))
|
2034 milliliters per day
Standard Deviation 527
|
SECONDARY outcome
Timeframe: 14 daysEstimate if participants consume similar average kcals of feed/day during the study, compared to baseline
Outcome measures
| Measure |
Patient Cohort
n=17 Participants
This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study.
|
|---|---|
|
Usability of Mobility+ (kcal)
Total enteral feed kcal consumed per day, at baseline
|
1848 kcal per day
Standard Deviation 604
|
|
Usability of Mobility+ (kcal)
Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21))
|
2034 kcal per day
Standard Deviation 527
|
Adverse Events
Patient Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Edel Keaveney, Senior Research Manager
Rockfield Medical Devices Ltd.
Phone: (+353) (0)91 763 000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place