Status:
TERMINATED
Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System
Lead Sponsor:
Nutriseal L.P
Conditions:
Enteral Nutrition
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the Nutriplace™ System guidance during the placement of the Nutriseal™ enteral feeding ...
Detailed Description
Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critic...
Eligibility Criteria
Inclusion
- Patients must be \>21 years of age
- Patients must require placement of a nasoenteral feeding tube
- Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
- Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent
Exclusion
- Patients must not have a history of:
- Esophageal varices or ulcers
- Upper airway obstruction
- Upper GI stenosis or obstruction
- Trauma involving sinuses, nares face or neck that would prevent Nasogastriv (NG) tube insertion
- Deformities of the sinus cavities and/or skull base
- Esophageal cancer or neoplasm
- Patients must not have a significant concomitant illness that would adversely affect their participation in the study
- Female patients who are pregnant or lactating
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03371160
Start Date
December 13 2017
End Date
March 15 2018
Last Update
June 18 2024
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195