Feasibility Study of Phototherapy System to Treat H Pylori - Tabular View

Tracking Information
First Received Date ^ICMJE	March 21, 2006
Last Updated Date	September 19, 2006
Start Date ^ICMJE	March 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2006)	Negative urease breath test at five weeks post procedure
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00306280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2006)	Procedural Side Effects Negative urease breath test at 5 days post procedure Reduction in acute post treatment bacterial population with respect to pretreatment samples
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Feasibility Study of Phototherapy System to Treat H Pylori
Official Title ^ICMJE	Phase 1 Study of Phototherapy System to Treat H Pylori
Brief Summary	This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
Detailed Description	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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Helicobacter Pylori
Intervention ^ICMJE	Device: Phototherapy
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	60
Completion Date	March 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00306280
Responsible Party
Study ID Numbers ^ICMJE	lmrx01
Study Sponsor ^ICMJE	LumeRx
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	LumeRx
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP