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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01401699
Other study ID # 2006-P-000203
Secondary ID 5R21CA141884
Status Completed
Phase N/A
First received
Last updated
Start date September 2006
Est. completion date November 16, 2011

Study information

Verified date January 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date November 16, 2011
Est. primary completion date November 16, 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Optical Frequency Domain Imaging (OFDI)
Optical Frequency Domain (OFDI) imaging of esophagus

Locations

Country Name City State
United States Massachussetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy. Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
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