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

Nasotrak Medical Pte Ltd

Status: Not yet enrolling

Conditions: Nasogastric Tube Placement

Treatments: Device: Nasotrak System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06497088

NST-DHF-076

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Nasotrak System

Experimental group

Treatment:

Device: Nasotrak System