Endoscopic Ultrasound (EUS) Processor Comparison
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 19 - 89 |
| Updated: | 4/21/2016 |
| Start Date: | March 2013 |
| End Date: | June 2013 |
Prospective Comparison of Two EUS Processors for Imaging of the Pancreas
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.
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.
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.
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.
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
We found this trial at
1
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Florida Hospital Florida Hospital is one of the country
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