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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04565704
Other study ID # 2015P000328
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 25, 2016
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.


Description:

The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology, Gastroenterology, and Pulmonology. They are looking to continue the advancement of these various technologies under development. The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and/or endo-mucosal resection.The endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies. The study will be optical imaging of the ex vivo GI specimens that are being collected. Specimens will be collected for research purposes only. Offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. This will require review of the medical record to link the findings of the imaging with the pertinent medical information. Samples will be de-identified and subjects will be assigned a unique number. The tissues will be placed in marked containers labeled "for research purposes only". The samples collected will be brought to the Tearney Research Laboratory for imaging and processing. The Optical imaging of the tissue samples will not affect the standard of care procedure.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: • Scheduled for an elective esophagoduodenoscopy and/or colonoscopy Exclusion Criteria: • According to standard of care at MGH endoscopy department.

Study Design


Intervention

Device:
Biopsy imaged by Optical imaging device.


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Device Feasibility based on image quality and presence of microscopic features The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches. Imaging data is collected during the procedure, and analyzed within 1 year of collection.
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