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Procedure

Gravitas Feeding Tube System for Nasogastric Tubes

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
Suitable to start enteral (gastric but not post-pyloric) feeding
Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube
Must not have
Has had removal of part of the stomach
Infant needs post-pyloric feeds (distal to stomach)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new feeding tube system for newborn babies in the NICU to see if it is safe and effective for giving them nutrition, fluids, and medications.

Who is the study for?
This trial is for newborns in intensive care or on a medical floor who need a nasogastric (NG) tube sized 5-8 Fr for feeding. They should be between 0 to 18 weeks old, can be up to 12 weeks premature, and must require enteral feeding for over 6 hours. Both ventilated and non-ventilated neonates are eligible if they have consent from a legal representative.
What is being tested?
The study tests the Gravitas Feeding Tube System's placement algorithm in neonates needing NG tubes. It assesses how well the system helps place tubes with or without monitor guidance, aiming to improve safety and effectiveness in delivering nutrition and medication.
What are the potential side effects?
While specific side effects aren't detailed here, typical risks may include irritation at the insertion site, discomfort during tube placement, potential misplacement of the tube, or infection risk associated with any invasive procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can start feeding through a tube in my stomach.
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I will need tube feeding for more than 6 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had part of my stomach surgically removed.
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My infant requires feeding beyond the stomach.
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I have a condition that significantly affects my stomach acid production.
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My infant has a fracture at the base of their skull.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gravitas FT SystemExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Gravitas Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
166 Total Patients Enrolled
2 Trials studying Nasogastric Tube
126 Patients Enrolled for Nasogastric Tube
~55 spots leftby Nov 2025
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