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Procedure
Entarik Feeding Tube System for Nasogastric Tube
N/A
Recruiting
Research Sponsored by Gravitas Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a feeding tube system for adults in an ICU to give nutrition, fluids and meds.
Who is the study for?
Adults in the ICU who can swallow tablets, need a nasogastric tube for nutrition and medications, and are expected to use it for more than 6 hours. They must be able to consent or have someone who can consent for them. Excluded are those with major GI issues, imminent death risk, MRI needs soon, pregnancy, or deemed unsuitable by the investigator.Check my eligibility
What is being tested?
The trial is testing the Entarik Feeding Tube System's safety and effectiveness in delivering nutrition and medication in adult ICU patients. One group will use the system with monitoring while another without monitoring to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort during placement, irritation of nasal passages or throat due to the tube presence, gastrointestinal complications like reflux or blockages, and possible infection risks at insertion sites.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EntarikExperimental Treatment1 Intervention
Entarik FT System guided placement
Group II: ControlActive Control1 Intervention
Entarik Ft placement placement not guided with monitor
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Who is running the clinical trial?
Gravitas Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
126 Total Patients Enrolled
2 Trials studying Nasogastric Tube
126 Patients Enrolled for Nasogastric Tube
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of delayed stomach emptying.I have a significant gastrointestinal condition or surgery history.I cannot have a feeding tube due to certain health issues like throat problems or frequent nosebleeds.I need a specific size feeding tube in the ICU.I need an MRI soon and my current feeding tube must be replaced for the procedure.I expect to be fed through a tube for more than 6 hours in the ICU.I can swallow pills.I am 18 years old or older.I am cleared to start feeding through a tube into my stomach.
Research Study Groups:
This trial has the following groups:- Group 1: Entarik
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation still have opportunities for enrolment?
"Yes, this medical study is still recruiting participants. The original trial was published on May 30th 2023 and the information has been updated as recently as June 1st of that same year."
Answered by AI
How many participants are taking part in this experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this research is presently seeking volunteers. The experiment was initially published on May 30th 2023 and has been recently updated on June 1st 2023. 110 participants are required from two distinct sites for enrollment in this trial."
Answered by AI
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