Feasibility Study of Phototherapy System to Treat H Pylori - Full Text View

Sponsored by:	LumeRx
Information provided by:	LumeRx
ClinicalTrials.gov Identifier:	NCT00306280

Purpose

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

Condition	Intervention
Helicobacter Pylori	Device: Phototherapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Study of Phototherapy System to Treat H Pylori

Further study details as provided by LumeRx:

Primary Outcome Measures:

Negative urease breath test at five weeks post procedure

Secondary Outcome Measures:

Procedural Side Effects
Negative urease breath test at 5 days post procedure
Reduction in acute post treatment bacterial population with respect to pretreatment samples

Estimated Enrollment:	60
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306280

Locations

United States, Massachusetts
Beth Israel Deaconness Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Anthony Lembo, MD 617-667-2138 alembo@bidmc.harvard.edu
Contact: Eoin Kelly, BS (617) 632 1108 eckelly@bidmc.harvard.edu
Principal Investigator: Anthony Lembo
Sub-Investigator: Sinil Sheth
UMass Memorial Medical Center	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: David Cave 508-856-8399 drcave@pol.net
Contact: Ann Foley (508) 334-4098 foleya@ummhc.org
Principal Investigator: David Cave
United States, Minnesota
Abbott Northwestern Hospital	Not yet recruiting
Minneapolis, Minnesota, United States, 55430
Contact: Robert Ganz, MD 612-871-1145 ext 82941 gastrodude@visi.com
Contact: Anne Hopper, BS (612) 870 5594 ahopper@mngastro.com
Principal Investigator: Robert Ganz

Sponsors and Collaborators

LumeRx

More Information

Study ID Numbers:	lmrx01
Study First Received:	March 21, 2006
Last Updated:	September 19, 2006
ClinicalTrials.gov Identifier:	NCT00306280
Health Authority:	United States: Food and Drug Administration

Keywords provided by LumeRx:

Helicobacter pylori
phototherapy
peptic ulcer
gastric cancer

Study placed in the following topic categories:

Ulcer
Stomach Neoplasms
Stomach cancer
Peptic Ulcer

ClinicalTrials.gov processed this record on January 14, 2009