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 range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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