A Phase 2 interventional study of PyloPlus UBT System and Histology in H. Pylori Infection, sponsored by ARJ Medical, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by ARJ Medical, Inc. · Phase 2, Interventional, and Diagnostic
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.
ARJ Medical, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.
Combination Product: PyloPlus UBT System · Diagnostic Test: Histology · Diagnostic Test: Rapid Urease Test · Diagnostic Test: H.pylori Culture
Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist
Biopsy specimen obtained and placed onto Rapid Urease Test
Biopsy specimen obtained and sent to lab for culture analysis
Overall Percent Agreement
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
Time frame: 2 Visits
| Milestone | Indication for H.Pylori Testing |
|---|---|
| Started | 415 |
| Completed | 324 |
| Not completed | 91 |
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
| percentage of pos. agreement | Indication for H.Pylori Testing |
|---|---|
| Sensitivity | 98.40 (91.7 to 99.7) |
| Specificity | 99.20 (97.2 to 99.8) |
Collected over 2 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indication for H.Pylori Testing | 0/324 (0%) | 0/324 (0%) | 0/324 (0%) |
| Age, Categorical(Participants) | Indication for H.Pylori Testing |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 203 |
| >=65 years | 121 |
| Sex: Female, Male(Participants) | Indication for H.Pylori Testing |
|---|---|
| Female | 220 |
| Male | 104 |
| Race/Ethnicity, Customized(Participants) | Indication for H.Pylori Testing |
|---|---|
| Asian | 3 |
| Black or African American | 13 |
| Hispanic | 59 |
| Other/Unknown/Not Reported | 116 |
| White | 133 |
| Region of Enrollment(Participants) | Indication for H.Pylori Testing |
|---|---|
| United States | 324 |
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Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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