Gravitas Feeding Tube System Placement Validation in Neonates

Last updated: November 19, 2025
Sponsor: Gravitas Medical, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Gravitas FT and Gravitas FT Monitor guidance

Gravitas FT System without placement guidance

Clinical Study ID

NCT05914064
CRD-04-1645-01
  • Ages < 2
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants in the Newborn Intensive Care Unit or on the general medical floor requiringa 5-8 Fr NG tube. The desired size of the feeding tube should be determinedclinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that sizeis 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 clinicallyindicated to receive a feeding tube.

  • If enteral nutrition has already been initiated, the orogastric/nasogastric feedingtube may be replaced with a Gravitas Feeding Tube.

  • Ability to have a legally authorized representative provide informed consent Bothneonates on a ventilator (non-invasive or invasive ventilation) or not requiring aventilator are eligible for this study.

Exclusion

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 siteprincipal investigator for any other reason

  • Requirement for post-pyloric feeds (distal to stomach)

  • Infant has a basilar skull fracture

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Gravitas FT and Gravitas FT Monitor guidance
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Lucile Packard (Stanford) Children's Hospital

    Stanford, California 94303
    United States

    Site Not Available

  • Lucile Packard (Stanford) Children's Hospital

    Stanford 5398563, California 5332921 94303
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah 4221552, Georgia 4197000 31404
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Women & Infants Hospital, Rhode Island

    Providence 5224151, Rhode Island 5224323 02905
    United States

    Site Not Available

  • University of Virginia Children's Health

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Children's Health

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

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