Gravitas Feeding Tube System Placement Validation in Neon... | NCT05914064

Studies
Gravitas Feeding Tube System Placement Validation in Neonates

NCT05914064

Sponsor

Gravitas Medical, Inc.

Status

Active, not recruiting

Last Update Posted

Nov 24, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Nasogastric Tube

Interventions

Gravitas FT and Gravitas FT Monitor guidance

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2023Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gravitas FT System	Experimental		Device: Gravitas FT and Gravitas FT Monitor guidance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gravitas FT and Gravitas FT Monitor guidance	Device	FT placed with guidance from the Gravitas FT system	Gravitas FT System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Weeks

Maximum Age

2 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Lucile Packard (Stanford) Children's Hospital		Stanford	California	94303	United States
Memorial Health University Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided