Enteral FeedingNCT06173063

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

A study testing Mobility+ Enteral Feeding System in people with Enteral Feeding, run by Rockfield Medical Devices at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 via enteral feeding. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Enteral Feeding
What is being tested?: Mobility+ Enteral Feeding System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2023to 6 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the 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 trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.

Conditions: Enteral Feeding
Being tested: Mobility+ Enteral Feeding System
Keywords: Enteral Feeding, Mobility, Quality of Life, Elastomeric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobility+ Enteral Feeding SystemDevice
Also called Mobility+, MOB
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.

Study groups in NCT06173063
Study group	Role	What they receive
Mobility+ Arm	Experimental	Adult patients using Mobility+ novel enteral feeding system for nutritional intake. Receives: Device: Mobility+ Enteral Feeding System

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume of Enteral Feed Consumed Per Day
Volume in mls of enteral feed consumed in total, and with Mobility+
Measured: 14 days

Secondary outcomes (6)

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).
Measured: 14 days
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).
Measured: 14 days
Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+
Measured: 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)
Measured: 14 days
Usability of Mobility+ (Volume)
Estimate if participants consume similar average volume of feed/day during the study, compared to baseline
Measured: 14 days
Usability of Mobility+ (kcal)
Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 20236 Nov 2024

First posted15 Dec 2023
Study start14 Nov 2023
Primary completion6 Nov 2024
Study completion6 Nov 2024

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Enteral FeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: 25 adult subjects from a screening population of 200
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06173063
Sponsor's protocol ID: CLP001
Status last verified: Dec 2025
First submitted: 23 Nov 2023
Last updated: 29 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

All Enteral Feeding trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.
ClinicalTrials.gov ID: NCT06173063
Acronym / sponsor ID: CLP001
Conditions: Enteral Feeding
Keywords: Enteral Feeding, Mobility, Quality of Life, Elastomeric
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 19 participants (actual)
Lead sponsor: Rockfield Medical DevicesIndustry (pharma, biotech, devices)
Collaborators: Horizon 2020 - European Commission
Study start: 14 Nov 2023 (actual)
Primary completion: 6 Nov 2024 (actual)
Study completion: 6 Nov 2024 (actual)
First posted: 15 Dec 2023 (actual)
Results: Posted 29 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 25 adult subjects from a screening population of 200

Arm	Type	Receives
Mobility+ Arm	Experimental	Device: Mobility+ Enteral Feeding SystemAdult patients using Mobility+ novel enteral feeding system for nutritional intake.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobility+ Enteral Feeding SystemAlso: Mobility+, MOBEnteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.	Device	Mobility+ Arm

Primary outcome

Volume of Enteral Feed Consumed Per Day
Time frame: 14 days
Volume in mls of enteral feed consumed in total, and with Mobility+

6 secondary outcomes

Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Time frame: 14 days
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
Time frame: 14 days
Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+
Time frame: 14 days
Participant Perspective on Quality of Life
Time frame: 14 days
Usability of Mobility+ (Volume)
Time frame: 14 days
Usability of Mobility+ (kcal)
Time frame: 14 days

Results and safety

Results posted to the registry on 29 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Cohort	19	17

Primary outcome: Volume of Enteral Feed Consumed Per Day

Time frame: 14 days. Mean (Standard Deviation). Unit: milliliters per day

Measure	Patient Cohort n = 17
Volume in milliliters of enteral feed consumed (Mobility+)	1050 (363)
Volume in milliliters of enteral feed consumed (other EN systems)	256 (294)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the duration of the study (21 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Cohort	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Enteral Feeding

RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manpreet Mundi principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mobility+ Enteral Feeding System in people with Enteral Feeding, run by Rockfield Medical Devices at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of Enteral Feed Consumed Per Day (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06173063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.