A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
NCT ID: NCT06497088
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-11-01
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement
NCT06821737
Ultrasound for Evaluation of Percutaneous G-tube Position
NCT06361498
Gastric Ultrasound in Tube Fed Intubated Patients
NCT04612348
Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy
NCT06375538
Use of Ultrasound Technology to Check Proper Placement of Tracheal and Endobronchial Tubes
NCT01553799
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nasotrak System
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 signals, thus assisting to track its location as an indicator of placement in the stomach. Nasotrak's NGT is intended only to be used with Nasotrak's HHD.
The Nasotrak NGT is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 signals, thus assisting to track its location as an indicator of placement in the stomach. Nasotrak's NGT is intended only to be used with Nasotrak's HHD.
The Nasotrak NGT is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nasotrak Medical Pte Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Tan, Beng
Role: STUDY_CHAIR
Nasotrak Medical Pte Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Columbia University Medical Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jan Powers, PhD
Role: backup
Michael Owen-Michaane, MD, MA, CNSC
Role: backup
David S. Seres, MD, ScM, PNS, FASPEN
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NST-DHF-076
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.