Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indication for Helicobacter pylori testing | Experimental | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreathID® Hp System | Device | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported Adverse Events | Number of participants with reported adverse events after performing urea breath test | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Agreement | Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection | 1 week |
| Percentage of Agreement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network | Shreveport | Louisiana | 71118 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
One subject (or parent) signed the consent, but before washout period was completed, decided to withdraw from trial. Therefore, from the 54 consented, only 53 started the study procedure.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Indication for Helicobacter Pylori Testing | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indication for Helicobacter Pylori Testing | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reported Adverse Events | Number of participants with reported adverse events after performing urea breath test | Posted | Count of Participants | Participants | 24 hours |
|
Up to 6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indication for Helicobacter Pylori Testing | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. BreathID® Hp System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea BreathID® Hp Lab System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Vomiting possibly induced by drinking of test substrate |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avraham Hershkowitz | Exalenz Bisocience | 972-8-9737513 | avrahamh@exalenz.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2017 | Jun 5, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009780 | Occult Blood |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Not provided
Not provided
The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Not provided
| BreathID® Hp Lab System | Drug | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
|
| Stool Test | Diagnostic Test | Each subject was asked to perform a stool test in parallel to the breath test. |
|
|
Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection
| 1 week |
| Gastrointestinal Associates |
| Flowood |
| Mississippi |
| 39232 |
| United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 10238 | United States |
| Children's Health - Children's Medical Center Dallas (UT Southwestern) | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77094 | United States |
| Assaf Harofe Medical Center | Tzrifin | 70300 | Israel |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Agreement | Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection | Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test. | Posted | Number | 95% Confidence Interval | percentage of pos. or neg. agreeement | 1 week |
|
|
|
| Secondary | Percentage of Agreement | Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection | Posted | Number | 95% Confidence Interval | percentage of pos. or neg. agreeement | 1 week |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 1 |
| 53 |
|
The Investigator shall be entitled to publish the Proprietary Data in scientific journals and other scientific and professional publications and oral dissertations and the like, provided that a draft of the intended publication or dissertation shall be submitted to the Company at least sixty (60) days before the date of intended publication or dissertation so as to enable the Company to make comments to the Center regarding the contents of such intended publication or dissertation.