Feasibility Study of Phototherapy System to Treat H Pylori
NCT ID: NCT00306280
Last Updated: 2006-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2006-03-31
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Phototherapy
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
Yes
Sponsors
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LumeRx
INDUSTRY
Locations
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Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Countries
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Facility Contacts
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Anthony Lembo, MD
Role: primary
Eoin Kelly, BS
Role: backup
David Cave
Role: primary
Ann Foley
Role: backup
Robert Ganz, MD
Role: primary
Anne Hopper, BS
Role: backup
Other Identifiers
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lmrx01
Identifier Type: -
Identifier Source: org_study_id