SuspendedNot Applicable

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

Stopped: Due to limited financial resource

Israel20 participantsStarted 2017-05-22

Plain-language 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

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patient 18 up to 90 years.
✓. Consecutive adult patients suffering from dysphagia with need for enteral feeding (PEG).
✓. Ability to give informed consent for the study by patient or legal guardian.
✓. Willingness to undergo 4 follow up visits 1, 3 and 4 months following PEG insertion/replacement, as well as unscheduled sick visits.

Exclusion criteria

✕. Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
✕. All current practice PEG contraindication
✕. Acute gastrointestinal bleeding
✕. Extreme obesity patients (BMI\>40)
✕. Emergency endoscopy
✕. Infectious disease local or systemic (e.g.- sepsis, pancreatitis)
✕. Known esophageal pathology (e.g.- stenosis, eosinophilic esophagitis, varices, achalasia)
✕. In case of PEG replacement: lack of a well healed gastrostomy or Infection around the insertion site.

What they're measuring

Treatment related Adverse Events

Timeframe: Through study completion, an average of 4 months

Trial details

NCT IDNCT03007511

SponsorFidmi Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-30

View on ClinicalTrials.gov More Feeding Tube trials