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Status:

UNKNOWN

Feasibility Study of Phototherapy System to Treat H Pylori

Lead Sponsor:

LumeRx

Conditions:

Helicobacter Pylori

Eligibility:

All Genders

18-90 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

End Date :

March 1 2007

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00306280

Start Date

March 1 2006

End Date

March 1 2007

Last Update

September 20 2006

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Beth Israel Deaconness Medical Center

Boston, Massachusetts, United States, 02215

2

UMass Memorial Medical Center

Worcester, Massachusetts, United States, 01655

3

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55430