Not yet recruiting NCT06497088
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nasotrak System.
- Who it may be relevant to
- Registry conditions: Nasogastric Tube Placement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body
Overview
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Interventions
- Device Nasotrak System
Device: The Nasotrak System The Nasotrak Medical System is intended to aid, in conjunction with institutional protocols, qualified operators in the placement of the Nasotrak's 12 Fr feeding tube into the stomach of patients requiring enteral feeding after insertion and before every feed. The Nasotrak nasogastric tube(NGT) is designed for use with Nasotrak's handheld device (HHD) which is able to detect the tip of the NGT via piezoelectric sensor, which converts ultrasound waves to electronic si
Primary outcome measures
- Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray. [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Parkview Regional Medical Center — Fort Wayne
- Columbia University Medical Center — New York
Identifiers
NCT: NCT06497088 · NST-DHF-076