Nasogastric Tube PlacementNCT06497088
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
A study testing Nasotrak System in people with Nasogastric Tube Placement, run by Nasotrak Medical Pte Ltd at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasogastric Tube Placement
- What is being tested?
- Nasotrak System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Jan Powers, PhD, (260) 266-7761, jan.powers@parkview.com
Jan Powers, PhD
Columbia University Medical Center
New York, New York, 10032
Amanda Alonso, 212-342-0261, aa2974@cumc.columbia.edu
Michael Owen-Michaane, MD, MA, CNSC
About this study
Official title: A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
- Conditions
- Nasogastric Tube Placement
- Being tested
- Nasotrak System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasotrak SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasotrak System | Experimental | Not described Receives: Device: Nasotrak System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray.
All patients will receive placement verification per institutional practice
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric Tube PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nasotrak Medical Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Tan, Beng, Study chair, Nasotrak Medical Pte Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497088
- Sponsor's protocol ID
- NST-DHF-076
- Status last verified
- Oct 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body
- ClinicalTrials.gov ID
- NCT06497088
- Acronym / sponsor ID
- NST-DHF-076
- Conditions
- Nasogastric Tube Placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nasotrak Medical Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasotrak System | Experimental | Device: Nasotrak System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasotrak SystemDevice: 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. | Device | Nasotrak System |
Primary outcome
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
All patients will receive placement verification per institutional practice
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tan, Beng study chair
Nasotrak Medical Pte Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasotrak System in people with Nasogastric Tube Placement, run by Nasotrak Medical Pte Ltd at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Tan (+65 6461 7016, david@nasotrak.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.