Endoscopic Ultrasound (EUS) Processor Comparison

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Brief Title

Endoscopic Ultrasound (EUS) Processor Comparison

Official Title

Prospective Comparison of Two EUS Processors for Imaging of the Pancreas

Brief Summary

      The primary objective for this study is to compare the image quality of two endoscopic
      ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to
      make a correct clinical diagnosis and higher quality imaging is related to more accurate
      results. Patient care may be improved due to the information collected as part of this study.

      The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas
      and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image
      resolution and depth of penetration. Good imaging enables diagnosis of early stage disease
      and thereby facilitates early treatment.
    

Detailed Description

      The endoscope is usually connected to a processor that generates an image which is viewed on
      a monitor. At FH, we use a processor called Aloka 10. A new processor is being developed by
      Olympus Corporation called EU-ME 2. This new processor is FDA approved, but has not been
      launched commercially yet. It has been loaned to FH for evaluation. We would like to evaluate
      this processor in an objective manner and hence the request for study approval.

      In this study, the endoscopy during the procedure will be attached to two different
      processors and images will be generated. The choice of which processor will be used first
      will be at the discretion of the Endoscopist. This does not require removal and
      reintroduction of the endoscope into the patient at two occasions. Only the connector will be
      switched to a different processor. So there is negligible risk to the patient.

      The time required for research activities will be between 5-10 minutes. Both processors will
      be set up in the procedure room for the duration of this study.

      The physician will then document the depth of penetration of the image (the farthest
      structure seen) and image resolution (evaluating the pancreas for subtle abnormalities). Both
      processors will be used for each patient. The scores for each processor will be documented to
      a procedure log, using the primary endpoint described above. The CRF will not have any
      patient information. Images viewed by the physician at the time of procedure will not be
      saved or recorded as part of this study..

      EUS will be performed in the standard fashion by one of the experienced endosonographers in
      the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope
      withdrawn from the patient.

      Patients will then be transported to the recovery area for observation as per standard
      policy. After appropriate observations are deemed satisfactory, patients will be discharged
      as per unit policy.
    


Study Type

Observational


Primary Outcome

image quality


Condition

Pancreatitis

Intervention

image quality and resolution

Study Arms / Comparison Groups

 Aloka
Description:  image quality and resolution

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

March 2013

Completion Date

June 2013

Primary Completion Date

May 2013

Eligibility Criteria

        Inclusion Criteria:

        All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreas will be
        included.

        Exclusion Criteria:

        Age <19 years Unable to safely undergo EUS for any reason
      

Gender

All

Ages

19 Years - 89 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shyam Varadarajulu, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01814631

Organization ID

409829


Responsible Party

Sponsor

Study Sponsor

AdventHealth


Study Sponsor

Shyam Varadarajulu, MD, Principal Investigator, AdventHealth


Verification Date

April 2016