Feeding TubeFidmiNCT03007511
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
A study testing Fidmi enhanced enteral feeding device in people with Feeding Tube and Dysphagia, run by Fidmi Medical at 2 sites in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Feeding Tube, Dysphagia
- What is being tested?
- Fidmi enhanced enteral feeding device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- 22 May 2017to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center
Jerusalem, Ein Kerem
Shaare Zedek Medical Center
Jerusalem, 9103102
About this study
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
Read the 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.
- Conditions
- Feeding Tube, Dysphagia
- Being tested
- Fidmi enhanced enteral feeding device
- Keywords
- Percutaneous Endoscopic Gastrostomy, Feeding tube, Enteral nutrition, Endoscopy, Gastrointestinal
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fidmi enhanced enteral feeding deviceDevice
Also called Low profile Gastrostomy, Percutaneous Endoscopic Gastrostomy (PEG) 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.
| Study group | Role | What they receive |
|---|---|---|
| Fidmi | Experimental | 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 Receives: Device: Fidmi enhanced enteral feeding device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Through study completion, an average of 4 months
Secondary outcomes (4)
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
Scored by the investigator performing the procedure
Measured: at Day 0
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
Scored by the investigator performing the procedure
Measured: at 3 Months
Accidental dislodgements
Number of accidental dislodgements during study follow up
Measured: until device removal at 3 months
Patient Pain
Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start22 May 2017
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Due to limited financial resource
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidmi Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Jacob Harold, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007511
- Sponsor's protocol ID
- Fidmi
- Acronym
- Fidmi
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2016
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
- ClinicalTrials.gov ID
- NCT03007511
- Acronym / sponsor ID
- Fidmi / Fidmi
- Conditions
- Feeding Tube, Dysphagia
- Keywords
- Percutaneous Endoscopic Gastrostomy, Feeding tube, Enteral nutrition, Endoscopy, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to limited financial resource
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fidmi MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fidmi | Experimental | Device: Fidmi enhanced enteral feeding devicePlacement 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fidmi enhanced enteral feeding deviceAlso: Low profile Gastrostomy, Percutaneous Endoscopic Gastrostomy (PEG) deviceFidmi 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. | Device | Fidmi |
Primary outcome
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
4 secondary outcomes
Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
Time frame: at Day 0
Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
Time frame: at 3 Months
Accidental dislodgements
Time frame: until device removal at 3 months
Patient Pain
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
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Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
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TubeClear System Evaluation in Pediatric Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Harold, MD principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fidmi enhanced enteral feeding device in people with Feeding Tube and Dysphagia, run by Fidmi Medical at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related Adverse Events (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.