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

NCT ID: NCT02430571

Last Updated: 2016-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-09-30

Brief 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. 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

Conditions

Enteral Nutrition, Feeding Tube Placement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. The subject or a legally authorized representative is able to understand and willing to give written informed consent.

3. Be a man or woman of 18 years or older

4. Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination

Exclusion Criteria

1. Women and men under the age of 18 years

2. Female patients who are known to be pregnant or lactating

3. Incarcerated or imprisoned individuals

4. Hemodynamic instability with an inability to maintain a MAP > 65 mm Hg on vasopressors

5. Patients who are currently enrolled in an investigational or interventional drug or device clinical trial

6. Patients who have been previously enrolled into this study

7. 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

8. Known basal skull fractures

9. Unrepaired known GI perforation or leak

10. Recent adequate upper GI bleed that may obscure images

11. Esophageal varices > Grade 2

12. Subjects with known anomalies precluding gastric or intestinal insertion (via either nasally or orally)

13. Known obstruction of the gastrointestinal tract

14. Known bowel ischemia or any other contraindication for enteral feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wischmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado School of Medicine

Aurora, Colorado, United States

Countries

United States

Other Identifiers

COVIRIS0465

Identifier Type: -

Identifier Source: org_study_id