CClinicalTrials.gg
Active, not recruitingNCT05914064Updated Nov 24, 2025

Gravitas Feeding Tube System Placement Validation in Neonates

An interventional study of Gravitas FT and Gravitas FT Monitor guidance in Nasogastric Tube, sponsored by Gravitas Medical, Inc.. Active, not recruiting at 5 sites in United States. Open to participants aged 0 Weeks to 2 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Gravitas Medical, Inc. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
0 Weeks to 2 Years
Sex
All
01

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.

02

Conditions studied

  • Nasogastric Tube
03

In context

Lead sponsor

Gravitas Medical, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Weeks to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is appropriate.
  • Age at enrollment: 0 to 2 years post-partum. Can be up to 15 weeks preterm (gestational age ≥ 25 weeks).
  • Suitable to start or continue gastric enteral feeding, or otherwise clinically indicated to receive a feeding tube.
  • If enteral nutrition has already been initiated, the orogastric/nasogastric feeding tube may be replaced with a Gravitas Feeding Tube.
  • Ability to have a legally authorized representative provide informed consent Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion criteria

Exclusion Criteria:

  • Known major upper airway malformation (e.g. tracheoesophageal fistula)
  • Known major GI malformation (e.g. malrotation, esophageal atresia, etc.)
  • History of gastrectomy or esophagectomy
  • Expected survival of less than one week
  • Neonate on ECMO
  • Deemed unsuitable for enrollment in study based on the judgement of the site principal investigator for any other reason
  • Requirement for post-pyloric feeds (distal to stomach)
  • Infant has a basilar skull fracture
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Gravitas FT System

    Device: Gravitas FT and Gravitas FT Monitor guidance

Interventions

  • DeviceGravitas FT and Gravitas FT Monitor guidance

    FT placed with guidance from the Gravitas FT system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

5 sites
  • Lucile Packard (Stanford) Children's Hospital
    Stanford, California 94303, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
  • Women & Infants Hospital, Rhode Island
    Providence, Rhode Island 02905, United States
  • University of Virginia Children's Health
    Charlottesville, Virginia 22903, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05914064
Lead sponsor
Gravitas Medical, Inc.
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Oct 27, 2023
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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