Feasibility Study of Phototherapy System to Treat H Pylori

H pylori causes almost all peptic ulcers and many gastric cancers and is widely prevalent
worldwide. Treatment by multiple antibiotics and proton pump inhibitors is effective but are
compromised today by significant non compliance due to side effects and duration of required
treatment. Also, the increase in antibiotic resistance coupled with the decreased
availability of new antibiotics project a significant population of patients who will not be
treatable with antibiotics.

A special, visible-light based phototherapy system has been demonstrated to significantly
decrease the viability of H pylori in vitro and in a brief clinical experiment.

This study will evaluate the safety and short term efficacy in up to 60 patients of the
phototherapy system to treat H pylori.

Inclusion Criteria:

- Age > 18 and < 90

- Documented positive for H. pylori infection by urease breath test, stool antigen or
histology within thirty days prior to procedure

- Willing to comply with study requirements

- Able to undergo endoscopic esophagogastroduodenoscopy (EGD) with biopsy

Exclusion Criteria:

- History of gastric or duodenal carcinoma

- History of prior gastric or duodenal surgery

- Oral or intravenous antibiotics use within previous one month

- Use of bismuth subsalicylate (Pepto Bismol) within previous one month

- Use of photosensitizing drugs or nutritional supplements within previous one month

- Active peptic ulcer disease (gastric or duodenal ulcer)

- Esophagitis Grade II or higher

- Oral or intravenous antibiotics use within previous one month

- History of a bleeding disorder or anti-coagulant use that would prevent biopsy

- PPI treatment two weeks prior to the scheduled endoscopy

- Positive Pregnancy Test

- Known porphyria

- Suffer from phenylketonuria (PKU)

- Signs of jaundice

- Weight < 100 lb or > 250 lb

- Previously enrolled in this study

- Participating in another ongoing clinical trial in which concomitant diagnosis or
therapeutic intervention would adversely affect the integrity of this study

- The subject is inappropriate for study participation, as determined by the
Investigator