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

Dysphagia Clinical Trial

— Fidmi  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03007511
• Other study ID #: Fidmi
• Status: Suspended
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Fidmi Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Feeding Tube

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem	Ein Kerem
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Fidmi Medical	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement	design outcome	at day 0
Primary	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	Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)	Scored by the investigator performing the procedure	at Day 0
Secondary	Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)	Scored by the investigator performing the procedure	at 3 Months
Secondary	Accidental dislodgements	Number of accidental dislodgements during study follow up	until device removal at 3 months
Secondary	Patient Pain	Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated	at 3 months

External Links

•   Fidmi Medical portfolio