TerminatedNot Applicable

Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

Stopped: Low recruitment rate

United States22 participantsStarted 2017-12-13

Plain-language 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 tubes.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Patients must not have a history of:
✕. Patients must not have a significant concomitant illness that would adversely affect their participation in the study
✕. Female patients who are pregnant or lactating

What they're measuring

Number of Participants With Successfully Placed Enteral Feeding Tube

Timeframe: During procedure visit

Trial details

NCT IDNCT03371160

SponsorNutriseal L.P

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-15

Results submitted2024-04-02

View on ClinicalTrials.gov More Enteral Nutrition trials