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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Enteral Nutrition, Feeding Tube Placement

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during the feeding tube placement procedure |