Feasibility Study of Phototherapy System to Treat H Pylori

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by LumeRx.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LumeRx
ClinicalTrials.gov Identifier:
NCT00306280
First received: March 21, 2006
Last updated: September 19, 2006
Last verified: September 2006

March 21, 2006
September 19, 2006
March 2006
Not Provided
Negative urease breath test at five weeks post procedure
Same as current
Complete list of historical versions of study NCT00306280 on ClinicalTrials.gov Archive Site
  • Procedural Side Effects
  • Negative urease breath test at 5 days post procedure
  • Reduction in acute post treatment bacterial population with respect to pretreatment samples
Same as current
Not Provided
Not Provided
 
Feasibility Study of Phototherapy System to Treat H Pylori
Phase 1 Study of Phototherapy System to Treat H Pylori

This purpose of this study is to determine whether phototherapy can be used to safely and effectively 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori
Device: Phototherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2007
Not Provided

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
Both
18 Years to 90 Years
Yes
United States
 
NCT00306280
lmrx01
Not Provided
Not Provided
LumeRx
Not Provided
Not Provided
LumeRx
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP