Phase 1 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Negative urease breath test at five weeks post procedure
United States: Food and Drug Administration
|Beth Israel Deaconness Medical Center||Boston, Massachusetts 02215|
|UMass Memorial Medical Center||Worcester, Massachusetts 01655|
|Abbott Northwestern Hospital||Minneapolis, Minnesota 55430|