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

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

Study Overview

• Status: Suspended
• Conditions: Dysphagia; Feeding Tube
• Intervention / Treatment: Device: Fidmi enhanced enteral feeding device

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Ein Kerem
    • Jerusalem, Ein Kerem, Israel
      • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
2. All current practice PEG contraindication
3. Acute gastrointestinal bleeding
4. Extreme obesity patients (BMI>40)
5. Emergency endoscopy
6. Infectious disease local or systemic (e.g.- sepsis, pancreatitis)
7. Known esophageal pathology (e.g.- stenosis, eosinophilic esophagitis, varices, achalasia)
8. In case of PEG replacement: lack of a well healed gastrostomy or Infection around the insertion site.
9. Known gastric pathology that may prevent safe device insertion, feeding, removal and Bumper flanges expulsion according to the investigator discretion.
10. Any history of bowel obstruction, pseudo-obstruction.
11. Crohn's disease
12. Recurrent vomiting
13. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
14. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fidmi; Placement of Fidmi enhanced enteral feeding device; internal tubes replacement during follow up and device removal after 3 month from placement Fidmi enhanced enteral feeding device

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.; Other Names: Low profile Gastrostomy; Percutaneous Endoscopic Gastrostomy (PEG) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related Adverse Events	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)	Scored by the investigator performing the procedure	at Day 0
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)	Scored by the investigator performing the procedure	at 3 Months
Accidental dislodgements	Number of accidental dislodgements during study follow up	until device removal at 3 months
Patient Pain	Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated	at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement	design outcome	at day 0

Collaborators and Investigators

• Sponsor: Fidmi Medical
• Collaborators: Hadassah Medical Organization
• Investigators: Principal Investigator: Jacob Harold, MD, Hadassah Medical Organization

Publications and helpful links

Helpful Links

• Fidmi Medical portfolio

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopy; Gastrointestinal; Enteral nutrition; Percutaneous Endoscopic Gastrostomy; Feeding tube
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: Fidmi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No