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Gravitas Feeding Tube System Placement Validation in Neonates

NCT05914064 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-24

No results posted yet for this study

Summary

The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.

Conditions

  • Nasogastric Tube

Interventions

DEVICE

Gravitas FT and Gravitas FT Monitor guidance

FT placed with guidance from the Gravitas FT system

Sponsors & Collaborators

  • Gravitas Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Weeks
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914064 on ClinicalTrials.gov