Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device (Fidmi)
Primary Purpose
Feeding Tube, Dysphagia
Status
Suspended
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Fidmi enhanced enteral feeding device
Sponsored by
About this trial
This is an interventional supportive care trial for Feeding Tube focused on measuring Percutaneous Endoscopic Gastrostomy, Feeding tube, Enteral nutrition, Endoscopy, Gastrointestinal
Eligibility Criteria
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.
- Known gastric pathology that may prevent safe device insertion, feeding, removal and Bumper flanges expulsion according to the investigator discretion.
- Any history of bowel obstruction, pseudo-obstruction.
- Crohn's disease
- Recurrent vomiting
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Sites / Locations
- Hadassah Medical Center
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fidmi
Arm Description
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
Outcomes
Primary Outcome Measures
Treatment related Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary Outcome Measures
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
Scored by the investigator performing the procedure
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
Scored by the investigator performing the procedure
Accidental dislodgements
Number of accidental dislodgements during study follow up
Patient Pain
Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated
Full Information
NCT ID
NCT03007511
First Posted
December 21, 2016
Last Updated
February 6, 2022
Sponsor
Fidmi Medical
Collaborators
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT03007511
Brief Title
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
Acronym
Fidmi
Official Title
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Suspended
Why Stopped
Due to limited financial resource
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidmi Medical
Collaborators
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Tube, Dysphagia
Keywords
Percutaneous Endoscopic Gastrostomy, Feeding tube, Enteral nutrition, Endoscopy, Gastrointestinal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fidmi
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Fidmi enhanced enteral feeding device
Other Intervention Name(s)
Low profile Gastrostomy, Percutaneous Endoscopic Gastrostomy (PEG) device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment related Adverse Events
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
Through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
Description
Scored by the investigator performing the procedure
Time Frame
at Day 0
Title
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
Description
Scored by the investigator performing the procedure
Time Frame
at 3 Months
Title
Accidental dislodgements
Description
Number of accidental dislodgements during study follow up
Time Frame
until device removal at 3 months
Title
Patient Pain
Description
Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated
Time Frame
at 3 months
Other Pre-specified Outcome Measures:
Title
Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement
Description
design outcome
Time Frame
at day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Known gastric pathology that may prevent safe device insertion, feeding, removal and Bumper flanges expulsion according to the investigator discretion.
Any history of bowel obstruction, pseudo-obstruction.
Crohn's disease
Recurrent vomiting
Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Harold, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Ein Kerem
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://trendlines.com/portfolio/fidmi/
Description
Fidmi Medical portfolio
Learn more about this trial
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
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