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Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device — Fidmi  

Dysphagia Clinical Trial

Official title:
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device

Clinical Trial Summary

A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device on 20 adult patients with a need for enteral feeding. The primary outcome will be to evaluate safety, usability and discomfort throughout the study

Clinical Trial Description

A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in patients that have feeding difficulties or are unable to maintain normal growth via oral feeds. Currently there are many solutions in the market for long-term enteral feeding, however none of them provide comfort and autonomy to their users, since they have a high probability of dislodgement, clogging, leakage and are bulky. The Fidmi Medical PEG Feeding Tube and Accessories are to provides food, liquids and medications into the stomach of patients who are having difficulty of swallowing. Fidmi Feeding Device is the first presented "low-profile device from day 1", easily hidden under clothing and not limiting mobility. Unlike other solutions, Fidmi device is resistant to dislodgement due to a semi-rigid internal bumper, and avoids clogging thanks to a disposable insert to deliver the nutrition. Fidmi device consists of 1) a rigid-core silicone bumper that prevents dislodgment, 2) a disposable internal tube replacement for a daily nutrition supply and prolonged patency, and 3) an external flexible bolster that keeps the stoma site ventilated and stable. The disposable insert is placed inside the feeding port and is replaced every 1-2 weeks to avoid clogging, extend the product life, and improve the cleanliness and hygiene of the tube. Disposable tube replacement is easy and safe and can be done by the patients themselves or their caregivers as the tract is never compromised and there is no need for a physician verification. The device is eventually removed in a simple procedure that can be done by the caregiver or patient themselves. Fidmi device obtain a tool that dismantles the internal bumper into small parts that are naturally expelled from the body for trauma free-removal. The Fidmi Feeding device would be inserted into eligible enrolled patients who would be followed up during a period of 3 months until device removal. Safety, usability and discomfort parameters would be monitored following 2, 30, 60, 90 and 120 days following the insertion procedure. In case a new Fidmi PEG device is requested by a patient: additional duration of 120 days±14 days will be added. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03007511
Study type Interventional
Source Fidmi Medical
Contact
Status Suspended
Phase N/A
Start date May 22, 2017
Completion date December 30, 2022
View Details
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