Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/30/2018 |
| Start Date: | September 2006 |
| End Date: | November 16, 2011 |
Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography
(OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a
clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using
the developed OCT imaging probe will be determined and compared with those obtained through
the traditional standard of care endoscopic biopsy .
(OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a
clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using
the developed OCT imaging probe will be determined and compared with those obtained through
the traditional standard of care endoscopic biopsy .
Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD)
procedures will be recruited for examination at the gastroesophageal junction with our
developed OCT imaging system. The patients will undergo a clinical EGD procedure including
endoscopic biopsy. The first step in the procedure follows the standard care with the
performance of the surveillance endoscopy. The study experimental procedure will then begin.
This study requires the use of a balloon . The balloon placement method is in accordance with
current standard clinical practice and involves the insertion of a guide wire through the
auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in
place, and the OCT balloon is inserted the required distance (determined during the
endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and
will remain in this fixed position throughout the entire procedure. Once the OCT imaging
probe is in place, OCT image data will be continuously collected over the length of the
balloon(approximately 5 cm).
It is expected that the total examination time including insertion and inflation of the OCT
balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the
total length of the EGD.
procedures will be recruited for examination at the gastroesophageal junction with our
developed OCT imaging system. The patients will undergo a clinical EGD procedure including
endoscopic biopsy. The first step in the procedure follows the standard care with the
performance of the surveillance endoscopy. The study experimental procedure will then begin.
This study requires the use of a balloon . The balloon placement method is in accordance with
current standard clinical practice and involves the insertion of a guide wire through the
auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in
place, and the OCT balloon is inserted the required distance (determined during the
endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and
will remain in this fixed position throughout the entire procedure. Once the OCT imaging
probe is in place, OCT image data will be continuously collected over the length of the
balloon(approximately 5 cm).
It is expected that the total examination time including insertion and inflation of the OCT
balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the
total length of the EGD.
Inclusion Criteria:
- over the age of 18,
- capable of giving informed consent,
- are undergoing elective EGD, and
- if female are willing to take a pregnancy test
Exclusion Criteria:
- patients on oral anticoagulation medications,
- with a history of hemostasis disorders and
- patients that are pregnant
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