Complication of Surgical ProcedureWNJNCT02005406
Testing the Efficacy and Safety of the WEI Nasal Jet
An observational study of Complication of Surgical Procedure, run by Zeyong Yang.
Trial summary
Testing the efficacy and safety of the WEI Nasal Jet. Read more about this study
- Who is it for?
- Ages 22 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of Surgical Procedure
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Apr 2013
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 22 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Suggested patient inclusion criteria: Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.
Who may be able to join
- Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.
Who cannot join
- Patients with coagulopathy and tendency of nose bleeding.
- Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.)
- Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.)
- Pregnant patients
- Patients with liver failure
- Patients with kidney failure
About this study
Official title: Efficacy and Safety of the WEI Nasal Jet
Testing the efficacy and safety of the WEI Nasal Jet.
Read the detailed description
This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Experimental group and control groupl
- Keywords
- Wei JET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group and control grouplDevice
Also called WEI, Control
JET
| Study group | Role | What they receive |
|---|---|---|
| wei group and control group | wei group(n=25) and control group(n=24) Receives: Device: Experimental group and control groupl |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowest SaO2 in Wei JET group
Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group.
Measured: 2 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical ProcedureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zeyong Yang
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor-investigator, Zeyong Yang, Fudan University
- Investigators
- Zeyong Yang, MD, Ph.D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005406
- Sponsor's protocol ID
- Wei JET
- Acronym
- WNJ
- Status last verified
- Dec 2013
- First submitted
- 3 Jul 2013
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang ZY, Meng Q, Xu YH, Wang JW, Yu DS, Wei HF. Supraglottic jet oxygenation and ventilation during colonoscopy under monitored anesthesia care: a controlled randomized clinical trial. Eur Rev Med Pharmacol Sci. 2016;20(6):1168-73.
PubMed 27049273
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the WEI Nasal Jet
- ClinicalTrials.gov ID
- NCT02005406
- Acronym / sponsor ID
- WNJ / Wei JET
- Conditions
- Complication of Surgical Procedure
- Keywords
- Wei JET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Zeyong YangUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2013 (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.
Testing the efficacy and safety of the WEI Nasal Jet.
Detailed description
This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wei group and control group | – | Device: Experimental group and control grouplwei group(n=25) and control group(n=24) |
Who may qualify
- Ages
- 22 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Suggested patient inclusion criteria: Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.
Key inclusion criteria (1 listed)
- Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.
Key exclusion criteria (6 listed)
- Patients with coagulopathy and tendency of nose bleeding.
- Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.)
- Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.)
- Pregnant patients
- Patients with liver failure
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 |
|---|---|---|
| Experimental group and control grouplAlso: WEI, ControlJET | Device | wei group and control group |
Primary outcome
lowest SaO2 in Wei JET group
Time frame: 2 second
Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group.
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 22 Dec 2016.
- Derived from this study: PubMed 27049273Yang ZY, Meng Q, Xu YH, Wang JW, Yu DS, Wei HF. Supraglottic jet oxygenation and ventilation during colonoscopy under monitored anesthesia care: a controlled randomized clinical trial. Eur Rev Med Pharmacol Sci. 2016;20(6):1168-73.
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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.
Zeyong Yang, MD, Ph.D principal investigator
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical Procedure, run by Zeyong Yang.
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 1 inclusion and 6 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 22 Dec 2016. 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.
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?
lowest SaO2 in Wei JET group (time frame: 2 second). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005406, which also lists 1 linked publication.
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 22 Dec 2016.