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Testing the Efficacy and Safety of the WEI Nasal Jet (WNJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005406
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 22, 2016
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Zeyong Yang, Fudan University

Brief Summary:
Testing the efficacy and safety of the WEI Nasal Jet.

Condition or disease Intervention/treatment
Complication of Surgical Procedure Device: Experimental group and control groupl

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 49 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Efficacy and Safety of the WEI Nasal Jet
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Group/Cohort Intervention/treatment
wei group and control group
wei group(n=25) and control group(n=24)
Device: Experimental group and control groupl
JET
Other Names:
  • WEI
  • Control




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
•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.


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005406


Sponsors and Collaborators
Zeyong Yang
University of Pennsylvania
Investigators
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Principal Investigator: Zeyong Yang, MD, Ph.D Shanghai Jiao Tong University School of Medicine

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zeyong Yang, Shanghai Jiaotong University, Fudan University
ClinicalTrials.gov Identifier: NCT02005406     History of Changes
Other Study ID Numbers: Wei JET
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2013

Keywords provided by Zeyong Yang, Fudan University:
Wei JET