A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.

Not Applicable

Not yet recruiting

• Conditions: Nasogastric Tube Placement
• Interventions: Device: Nasotrak System

• Registration Number: NCT06497088
• Lead Sponsor: Nasotrak Medical Pte Ltd

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Study Start: 2024-11-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults greater than 18 years of age
• Able to provide informed consent or have a legally authorized representative available to provide informed consent in English
• Clinically requiring a 12 Fr NG/OG tube with X-ray confirmation per standard protocol

Exclusion Criteria

• Female subjects of childbearing age with known pregnancy or lactating.
• Prisoners.
• Unable to consent in English.
• Subjects/ volunteers with pacemakers or life-sustaining devices in the body such as ICD.
• Subjects with a history of:
• Esophageal varices or ulcers.
• Upper airway obstruction.
• Upper GI stenosis or obstruction.
• Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion.
• Deformities of the sinus cavities and/or skull base.
• Esophageal cancer or neoplasm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasotrak System	Nasotrak System	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray.	1 year	All patients will receive placement verification per institutional practice

Trial Locations

Locations (2)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Parkview Regional Medical Center; 🇺🇸 Fort Wayne, Indiana, United States