A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body. (NCT06497088) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
United States90 participantsStarted 2024-11-01
Plain-language summary
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray.