Enteral Nutrition, Feeding Tube PlacementNCT02430571
Case Series to Evaluate the Identification of Anatomical Markers Using the KANGAROO™ Feeding Tube
An observational study of Enteral Nutrition, Feeding Tube Placement, run by Medtronic - MITG at 1 site in United States.
Trial summary
This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition, Feeding Tube Placement
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring nasogastric feeding tube in an ICU or step-down unit
Who may be able to join
- Hospitalized male and female patients in a monitored setting (i.e.; ICU or Step-Down Unit) who require and are eligible for short-term enteral (nasal or oral) feeding per standard of care with an expected duration of at least 3 days.
- The subject or a legally authorized representative is able to understand and willing to give written informed consent.
- Be a man or woman of 18 years or older
- Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination
Who cannot join
- Women and men under the age of 18 years
- Female patients who are known to be pregnant or lactating
- Incarcerated or imprisoned individuals
- Hemodynamic instability with an inability to maintain a MAP > 65 mm Hg on vasopressors
- Patients who are currently enrolled in an investigational or interventional drug or device clinical trial
- Patients who have been previously enrolled into this study
Show all 14Show fewer
- Individuals, who, in the opinion of the Principal Investigator, have any medical, social or psychological condition that would compromise their participation and follow-up in this clinical investigation
- Known basal skull fractures
- Unrepaired known GI perforation or leak
- Recent adequate upper GI bleed that may obscure images
- Esophageal varices > Grade 2
- Subjects with known anomalies precluding gastric or intestinal insertion (via either nasally or orally)
- Known obstruction of the gastrointestinal tract
- Known bowel ischemia or any other contraindication for enteral feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Official title: A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube With IRIS Technology
This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary, written informed consent to participate in the clinical investigation will be included as subjects. If a potential subject is incapacitated and unable to provide informed consent, a designated legally authorized representative will be allowed to provide the informed consent on behalf of the subject to allow their participation in the study. Study entry will be defined as the point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube
the following anatomical structures will be noted if visualized and the depth of feeding tube will also be recorded corresponding to the visualized structure: trachea/carina, esophagus, stomach
Measured: during the feeding tube placement procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Nutrition, Feeding Tube PlacementStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430571
- Sponsor's protocol ID
- COVIRIS0465
- Status last verified
- Nov 2016
- First submitted
- 27 Apr 2015
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube With IRIS Technology
- ClinicalTrials.gov ID
- NCT02430571
- Acronym / sponsor ID
- COVIRIS0465
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Apr 2015 (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.
This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary, written informed consent to participate in the clinical investigation will be included as subjects. If a potential subject is incapacitated and unable to provide informed consent, a designated legally authorized representative will be allowed to provide the informed consent on behalf of the subject to allow their participation in the study. Study entry will be defined as the point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring nasogastric feeding tube in an ICU or step-down unit
Key inclusion criteria (4 listed)
- Hospitalized male and female patients in a monitored setting (i.e.; ICU or Step-Down Unit) who require and are eligible for short-term enteral (nasal or oral) feeding per standard of care with an expected duration of at least 3 days.
- The subject or a legally authorized representative is able to understand and willing to give written informed consent.
- Be a man or woman of 18 years or older
- Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination
Key exclusion criteria (14 listed)
- Women and men under the age of 18 years
- Female patients who are known to be pregnant or lactating
- Incarcerated or imprisoned individuals
- Hemodynamic instability with an inability to maintain a MAP > 65 mm Hg on vasopressors
- Patients who are currently enrolled in an investigational or interventional drug or device clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube
Time frame: during the feeding tube placement procedure
the following anatomical structures will be noted if visualized and the depth of feeding tube will also be recorded corresponding to the visualized structure: trachea/carina, esophagus, stomach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
Paul Wischmeyer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Nutrition, Feeding Tube Placement, run by Medtronic - MITG at 1 site in United States.
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: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube (time frame: during the feeding tube placement procedure). 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 30 Nov 2016.