Status:
NOT_YET_RECRUITING
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
Lead Sponsor:
Nasotrak Medical Pte Ltd
Conditions:
Nasogastric Tube Placement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06497088
Start Date
November 1 2024
End Date
June 30 2025
Last Update
October 15 2024
Active Locations (2)
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1
Parkview Regional Medical Center
Fort Wayne, Indiana, United States, 46845
2
Columbia University Medical Center
New York, New York, United States, 10032