Gravitas Feeding Tube System Placement Validation in Neonates

NCT05914064 | Active Not Recruiting FDA Device

• 1 other identifier: CRD-04-1645-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

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.

  1 year

Study Arms (1)

Gravitas FT System

EXPERIMENTAL

Device: Gravitas FT and Gravitas FT Monitor guidance

Interventions

Gravitas FT and Gravitas FT Monitor guidance DEVICE

FT placed with guidance from the Gravitas FT system

Gravitas FT System

Eligibility Criteria

• Age: 0 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gravitas Medical, Inc.: lead

Study Sites (5)

Lucile Packard (Stanford) Children's Hospital

Stanford, California, 94303, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Women & Infants Hospital, Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Virginia Children's Health

Charlottesville, Virginia, 22903, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 22, 2023
• Study Start: October 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)