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Optical Imaging for Gastrointestinal Disorders

N/A

Waitlist Available

Led By Guillermo Tearney, M.D, PhD.

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging data is collected during the procedure, and analyzed within 1 year of collection.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new optical imaging technologies to see if they can be used to detect and diagnose diseases of the gastrointestinal system without being destructive or invasive.

Who is the study for?

This trial is for individuals scheduled for an elective esophagoduodenoscopy and/or colonoscopy, typically procedures to look inside the stomach and colon. It's not open to those who don't meet the Massachusetts General Hospital (MGH) endoscopy department's standard care criteria.

What is being tested?

The study is testing a new optical imaging device designed to image gastrointestinal biopsy samples. The goal is to see if this technology can help diagnose diseases of the gastrointestinal system without being too invasive or damaging tissue.

What are the potential side effects?

Since this trial involves imaging already-scheduled biopsy samples with a new device, there are no direct side effects from the intervention itself. However, standard risks associated with biopsies still apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging data is collected during the procedure, and analyzed within 1 year of collection.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~imaging data is collected during the procedure, and analyzed within 1 year of collection.

This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging data is collected during the procedure, and analyzed within 1 year of collection. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device Feasibility based on image quality and presence of microscopic features

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Development of novel optical imaging technologiesExperimental Treatment1 Intervention

Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.

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