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

February 6, 2022 updated by: Fidmi Medical
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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment related Adverse Events
Time Frame: Through study completion, an average of 4 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
Time Frame: at Day 0
Scored by the investigator performing the procedure
at Day 0
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
Time Frame: at 3 Months
Scored by the investigator performing the procedure
at 3 Months
Accidental dislodgements
Time Frame: until device removal at 3 months
Number of accidental dislodgements during study follow up
until device removal at 3 months
Patient Pain
Time Frame: at 3 months
Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated
at 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement
Time Frame: at day 0
design outcome
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fidmi Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hadassah Medical Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacob Harold, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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