Testing the Efficacy and Safety of the WEI Nasal Jet

Complication of Surgical Procedure Clinical Trial

— WNJ  

Official title:

Efficacy and Safety of the WEI Nasal Jet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005406
• Other study ID #: Wei JET
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: December 21, 2016
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Testing the efficacy and safety of the WEI Nasal Jet.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 58 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

Device:
• Experimental group and control groupl
JET

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zeyong Yang	University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lowest SaO2 in Wei JET group	Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group.	2 second	Yes