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Procedure

Gravitas FT 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gravitas FT SystemExperimental Treatment1 Intervention

Group II: ControlActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study include individuals who are older than 55 years of age?

"The recruitment for this research endeavor includes individuals above 0 weeks and below 18 weeks of age."

Answered by AI

Is the enrollment process currently ongoing for individuals interested in participating in this trial?

"Indeed, the details provided on clinicaltrials.gov suggest that this specific trial is actively inviting participants. First shared on October 27th, 2023, it was last modified on February 23rd, 2024. The investigation aims to enroll a total of 110 patients spread across three distinct sites."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"To commence the research, a pool of 110 eligible participants is required. The study will be overseen by Gravitas Medical, Inc., and will take place at various locations such as University of Virginia Children's Health in Charlottesville, Virginia and Lucile Packard (Stanford) Children's Hospital in Stanford, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gravitas Feeding Tube System Placement Validation in Neonates

2023. "Gravitas Feeding Tube System Placement Validation in Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05914064.