Feasibility Study of Phototherapy System to Treat H Pylori
Status unconfirmed · Not applicable
Conditions studied: Helicobacter Pylori
In brief
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
Key facts
- Study ID
- NCT00306280
- Run by
- LumeRx
- People needed
- 60
- Starts
- 2006-03-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2006-09-20
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States (enrolling)
- UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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