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OpenTrials
Active, Not Recruiting

NCT Number: NCT05914064

Gravitas Feeding Tube System Placement Validation in Neonates

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Nasogastric Tube

Age range

0 week–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard (Stanford) Children's Hospital, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Gravitas FT and Gravitas FT Monitor guidance

Device

FT placed with guidance from the Gravitas FT system

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

Sponsors and collaborators

Lead sponsor

Gravitas Medical, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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