NCT03007511

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

5.4 years

First QC Date

December 21, 2016

Last Update Submit

February 6, 2022

Conditions

Feeding TubeDysphagia

Keywords

Percutaneous Endoscopic GastrostomyFeeding tubeEnteral nutritionEndoscopyGastrointestinal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)

    at Day 0

  • Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)

    at 3 Months

  • Accidental dislodgements

    until device removal at 3 months

  • Patient Pain

    at 3 months

Other Outcomes (1)

  • Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement

    at day 0

Study Arms (1)

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

Device: Fidmi enhanced enteral feeding device

Interventions

Fidmi enhanced enteral feeding deviceDEVICE

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.

Also known as: Low profile Gastrostomy, Percutaneous Endoscopic Gastrostomy (PEG) device
Fidmi

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Center

Jerusalem, Ein Kerem, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jacob Harold, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 2, 2017

Study Start

May 22, 2017

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)