Abstract
An upper endoscope is designed for the endoscopic evaluation of the esophagus, stomach
and duodenum, however, of the six-million upper endoscopies performed annually in the US,
about half are for the disorders of the esophagus alone, where it can be argued that a full
endoscopy of these three organs is not necessary in many, particularly since the procedure
requires sedation with its associated risk and expense. Sedation adds to the risk of
complications and increases expense. The high cost also adds to healthcare disparities. We
propose a safer, cost-effective and convenient alternative by developing a market-ready high-
resolution endoscopic tool that will allow patients to have an un-sedated inspection of the
esophagus, affordably and in the convenience of their doctor’s office.
Our device would be most effective in the evaluation of patients with gastro-esophageal reflux
symptoms and to screen for its complication, Barrett’s esophagus, both of which are highly
prevalent. Since Barrett’s esophagus is found in about 15% of patients with chronic reflux
symptoms, visually confirming its absence will allow 85% of patients to avoid a standard
endoscopy with biopsies which would be needed for only 15% of patients. It will also allow
screening for esophageal varices in patients with chronic liver disease and allow widespread
affordable screening for squamous cell cancer in other parts of the world.
We have developed a reusable tethered capsule with a forward- and rear- facing cameras,
capable of white- light and narrow-band imaging with a degree of resolution beyond the reach
of current endoscopes. The compact capsule is smaller than current wireless capsules and
was developed after consultations with physicians, marketing and sales personnel in
endoscopy. Development was guided by meetings with the FDA, which recommended that
we proceed with bench tests followed by a clinical evaluation. The clinical study will be led by
an expert researcher in esophageal disease and endoscopy. We are collaborating with a
marketing group known for successfully launching gastrointestinal endoscopic devices in the
US and overseas. Our reusable high-resolution imaging device will allow the esophagus and
proximal stomach to be examined easily, safely and affordably (at a fraction of the cost of a
standard upper endoscopy) for a transformational effect on endoscopic practice. It will help
detect common diseases in more people, prevent cancer and save lives.