Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

Barrett's Esophagus Clinical Trial

Official title:

Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401699
• Other study ID #: 2006-P-000203
• Secondary ID: 5R21CA141884
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

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