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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439633
Other study ID # 2010-P-000553
Secondary ID 2R01CA103769-06A
Status Completed
Phase N/A
First received
Last updated
Start date October 2010
Est. completion date May 2014

Study information

Verified date April 2019
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 feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.


Description:

Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.

Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.

It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length

- Patients must be over the age of 18

- Patient must be able to give informed consent

- Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria:

- Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure

- Patients with a history of hemostasis disorders

- Patients that are pregnant

- Patients with esophageal strictures

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MGH OFDI marking
Imaging of esophagus with OFDI system

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue. day 1, during diagnostic procedure
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