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

NCT03007511 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-02-23

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Fidmi enhanced enteral feeding device

Fidmi enhanced enteral feeding device is intended to provide nutrition to a patient directly into the stomach through a stoma. The Fidmi PEG device would be investigated in this study on patients suffering from dysphagia, who are scheduled for PEG procedure in order to improve surgical initial insertion, device replacement and removal.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Fidmi Medical

    lead INDUSTRY

Principal Investigators

  • Jacob Harold, MD · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2022-10-30
Completion
2022-12-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007511 on ClinicalTrials.gov