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OpenTrials
Completed

NCT Number: NCT02430571

Case Series to Evaluate the Identification of Anatomical Markers Using the KANGAROO™ Feeding Tube

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2015
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.