Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306280
Status:
UNKNOWN
Last Update Posted:
2006-09-20
First Post:
2006-03-21
Brief Title:
Feasibility Study of Phototherapy System to Treat H Pylori
Sponsor:
LumeRx
Organization:
LumeRx
Study Overview
Official Title:
Phase 1 Study of Phototherapy System to Treat H Pylori
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None