Intubation, NasogastricPhase 2NCT00781248
Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage
A Phase 2 study testing NG Shield in people with Intubation, Nasogastric, run by Nanovibronix at 1 site in Israel.
Trial summary
The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Nasogastric
- What is being tested?
- NG Shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
- Subject is able to understand and answer the pain and discomfort questionnaires
- Subject has been fasting for at least 12h prior to the insertion phase
- Subject underwent a physical examination by the PI
- Subject able, agrees and signs the Inform Consent Form (ICF)
Who cannot join
- Subject has any history of dysphagia or esophageal disease
- Subject used anti pain medications during the last week prior to the study date
- Subject used Antibiotics during the last week prior to the study date
- Subject with Asthma
- Subject with chronic or acute nasal or throat disorder
- Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
Show all 9Show fewer
- Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
- Subject has any condition, which precludes compliance with study and/or device instruction for use
- Subject is currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations
- Conditions
- Intubation, Nasogastric
- Being tested
- NG Shield
- Keywords
- enteral feeding, Subject who requires nasogastric tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG ShieldDevice
A device to reduce pain/discomfort related to nasogastric tube usage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | starting with active NG Shield Receives: Device: NG Shield |
| 2 | Experimental | Starting with inactive NG Shield Receives: Device: NG Shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
Measured: every 30 minutes for 6 hours
safety of device usage
Measured: 6 hours
Secondary outcomes (1)
pain/Dicomfort during insertion and removal of the nasogastric tube
Measured: at t=0h and t=6h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, NasogastricStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanovibronix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shmuel Adler, M.D, Principal investigator, "Bikur Cholim" Hospital, Jerusalem ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781248
- Sponsor's protocol ID
- NV-NGS-06-001
- Status last verified
- Mar 2009
- First submitted
- 26 Oct 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
- ClinicalTrials.gov ID
- NCT00781248
- Acronym / sponsor ID
- NV-NGS-06-001
- Conditions
- Intubation, Nasogastric
- Keywords
- enteral feeding, Subject who requires nasogastric tube
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NanovibronixIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Oct 2008 (estimated)
- 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 the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: NG Shieldstarting with active NG Shield |
| 2 | Experimental | Device: NG ShieldStarting with inactive NG Shield |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
- Subject is able to understand and answer the pain and discomfort questionnaires
- Subject has been fasting for at least 12h prior to the insertion phase
- Subject underwent a physical examination by the PI
- Subject able, agrees and signs the Inform Consent Form (ICF)
Key exclusion criteria (9 listed)
- Subject has any history of dysphagia or esophageal disease
- Subject used anti pain medications during the last week prior to the study date
- Subject used Antibiotics during the last week prior to the study date
- Subject with Asthma
- Subject with chronic or acute nasal or throat disorder
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 |
|---|---|---|
| NG ShieldA device to reduce pain/discomfort related to nasogastric tube usage | Device | 1, 2 |
Primary outcome
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
Time frame: every 30 minutes for 6 hours
safety of device usage
Time frame: 6 hours
1 secondary outcome
pain/Dicomfort during insertion and removal of the nasogastric tube
Time frame: at t=0h and t=6h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
Related trials for Intubation, Nasogastric
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Recruiting
Comparing Mixed Reality, Video-Based, and Instructor-Led Training for Nasogastric Tube Insertion in Nursing Students
Education, Nursing Students, Clinical Competence
Not yet recruiting
Comparing Two Methods to Measure Nasogastric Tube Length
Intubation, Nasogastric, Intubation Intraesophageal
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.
Shmuel Adler, M.D principal investigator
"Bikur Cholim" Hospital, Jerusalem ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NG Shield in people with Intubation, Nasogastric, run by Nanovibronix at 1 site in Israel.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase (time frame: every 30 minutes for 6 hours). The study lists 2 primary outcomes in all. 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 25 Mar 2009.