Clinical trial · Interventional
Feasibility Study of Phototherapy System to Treat H Pylori
Phase 1 Study of Phototherapy System to Treat H Pylori
NCT00306280CI-TRIAL-00000455unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Helicobacter Pylori | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phototherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Negative urease breath test at five weeks post procedure
Secondary outcomes (3)
- measure
- Procedural Side Effects
- measure
- Negative urease breath test at 5 days post procedure
- measure
- Reduction in acute post treatment bacterial population with respect to pretreatment samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.