A Study to Evaluate the Mobility+ System and Its Usability
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-004892
Sponsor Protocol Number: PR001 Mobility+
About this study
The purpose of this study is to determine the sufficiency of the instructions for use, demonstration video, and labeling relating to the Mobility+ system from users, caregivers, and healthcare professionals. This evaluation will enable Rockfield Medical Devices to assess the usability of Mobility+, ensure user and patient safety are prioritized and adequate information on use, precautions, warnings, and contraindications are provided as appropriate.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Group 1: Novices to Home enteral nutrition (Minimum n=15)
- Group 2: Non-novices (experienced in enteral feeding) (Minimum n=15)
- Group 3: Healthcare professionals (dietitians, nurses) (Minimum of n=15)
Exclusion Criteria:
- Users who exclusively use blenderized feed.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Manpreet Mundi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available