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Feasibility Study of Phototherapy System to Treat H Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00306280
Recruitment Status : Unknown
Verified September 2006 by LumeRx.
Recruitment status was:  Recruiting
First Posted : March 23, 2006
Last Update Posted : September 20, 2006
Sponsor:
Information provided by:
LumeRx

Tracking Information
First Submitted Date  ICMJE March 21, 2006
First Posted Date  ICMJE March 23, 2006
Last Update Posted Date September 20, 2006
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
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
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori
Intervention  ICMJE Device: Phototherapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: March 21, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00306280
Other Study ID Numbers  ICMJE lmrx01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE LumeRx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account LumeRx
Verification Date September 2006

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