StrokeEarly Phase 1NCT01649349
The Feasibility Study of Dual-Section Nasogastric Tube
A Early Phase 1 study testing two-piece nasogastric tube in people with Stroke and Mouth Neoplasms, run by Changhua Christian Hospital.
Trial summary
The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Mouth Neoplasms
- What is being tested?
- two-piece nasogastric tube
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2012
- Phase
- Early Phase 1
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dysphagia
- mouth neoplasms
- stroke
- already use conventional nasogastric tube for at least 2 weeks
Who cannot join
- unconsciousness patient
- unstable medical condition with needs of closely medical care
- unable to fill in inform consent
- the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube
About this study
Official title: The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients
The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.
- Conditions
- Stroke, Mouth Neoplasms
- Being tested
- two-piece nasogastric tube
- Medical subject headings
- Stroke, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-piece nasogastric tubeDevice
one week period
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events.
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Secondary outcomes (1)
satisfaction of Dual-Section Nasogastric Tube
using Likert scale for overall satisfaction
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsung Ju Wu, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649349
- Sponsor's protocol ID
- 110807
- Other IDs
- TW201010751
- Status last verified
- Jul 2012
- First submitted
- 29 Jun 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients
- ClinicalTrials.gov ID
- NCT01649349
- Acronym / sponsor ID
- 110807
- Conditions
- Stroke, Mouth Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jul 2012 (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 this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- dysphagia
- mouth neoplasms
- stroke
- already use conventional nasogastric tube for at least 2 weeks
Key exclusion criteria (4 listed)
- unconsciousness patient
- unstable medical condition with needs of closely medical care
- unable to fill in inform consent
- the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube
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 |
|---|---|---|
| two-piece nasogastric tubeone week period | Device | – |
Primary outcome
Number of Participants with Adverse Events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events.
1 secondary outcome
satisfaction of Dual-Section Nasogastric Tube
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
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 Jul 2012.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing two-piece nasogastric tube in people with Stroke and Mouth Neoplasms, run by Changhua Christian Hospital.
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 4 inclusion and 4 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of Participants with Adverse Events (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks). 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 Jul 2012.