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The study was terminated after the enrollment of 19 participants due to difficulties in recruitment (an enrollment of 25 participants was originally planned). No safety concerns were raised and no adverse events occurred.
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| Name | Class |
|---|---|
| Horizon 2020 - European Commission | OTHER |
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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:
Participants will use Mobility+ enteral feeding system as their enteral feeding method for the duration of the study and will record their experiences.
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 trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobility+ Arm | Experimental | Adult patients using Mobility+ novel enteral feeding system for nutritional intake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobility+ Enteral Feeding System | Device | Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Enteral Feed Consumed Per Day | Volume in mls of enteral feed consumed in total, and with Mobility+ | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Subjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1). | 14 days |
| Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manpreet Mundi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Cohort | This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Cohort | This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of Enteral Feed Consumed Per Day | Volume in mls of enteral feed consumed in total, and with Mobility+ | Posted | Mean | Standard Deviation | milliliters per day | 14 days |
|
|
Adverse event data was collected for the duration of the study (21 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Cohort | This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edel Keaveney, Senior Research Manager | Rockfield Medical Devices Ltd. | (+353) (0)91 763 000 | edel@rockfieldmd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2023 | Nov 26, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2025 | Nov 26, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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25 adult subjects from a screening population of 200
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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). |
| 14 days |
| Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+ | 14 days |
| Participant Perspective on Quality of Life | Subjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1) | 14 days |
| Usability of Mobility+ (Volume) | Estimate if participants consume similar average volume of feed/day during the study, compared to baseline | 14 days |
| Usability of Mobility+ (kcal) | Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline | 14 days |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilogram |
|
| Height | Mean | Standard Deviation | Centimetres |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram per square metre |
|
| EN formula consumed | Mean | Standard Deviation | milliliters per day |
|
| EN daily calories | Mean | Standard Deviation | kcal per day |
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| Daily EN feeding sessions | Mean | Standard Deviation | Feeding sessions per day |
|
| Total infusion time | Mean | Standard Deviation | hours per day |
|
|
| Secondary | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Subjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1). | Posted | Mean | Standard Deviation | Scores on a scale | 14 days |
|
|
|
| Secondary | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | 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). | Posted | Mean | Standard Deviation | Scores on a scale | 14 days |
|
|
|
| Secondary | Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+ | 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. | Posted | 14 days |
|
|
| Secondary | Participant Perspective on Quality of Life | Subjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1) | Posted | Mean | Standard Deviation | Scores on a scale | 14 days |
|
|
|
| Secondary | Usability of Mobility+ (Volume) | Estimate if participants consume similar average volume of feed/day during the study, compared to baseline | Posted | Mean | Standard Deviation | milliliters per day | 14 days |
|
|
|
| Secondary | Usability of Mobility+ (kcal) | Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline | Posted | Mean | Standard Deviation | kcal per day | 14 days |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Title | Measurements |
|---|---|
|
| Going up and down stairs (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| Short walk (e.g 1 block) (Baseline) |
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| Short walk (e.g. 1 block) (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
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| Long walk (e.g. several blocks) (Baseline) |
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| Long walk (e.g. several blocks) (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
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| Travelling in car/public transport (Baseline) |
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| Travelling in car/public transport (End of Study post 14 d feeding w/ Mobility+ (Day 21) |
|
| Moderate intensity physical activities (Baseline) |
|
| Moderate intensity physical activities (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
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| Other daily activities (high intensity physical activities) (Baseline) |
|
| Other daily high intensity physical activities(End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| Ability to sleep (Baseline) |
|
| Ability to sleep (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| Socializing with friends/family (Baseline) |
|
| Socializing with friends/family (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| Title | Measurements |
|---|---|
|
| System is easy to carry (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| The noise level of system is acceptable (Baseline) |
|
| The noise level of system is acceptable (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
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| System allows me to feed discreetly (Baseline) |
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| System allows me to feed discreetly (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| I am satisfied with the overall performance of the system (Baseline) |
|
| I'm satisfied with overall system performance (End of Study post 14 d feeding w/ Mobility+ (Day 21)) |
|
| Title |
|---|
| Measurements |
|---|
|
| Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21)) |
|