[Trial of device that is not approved or cleared by the U.S. FDA]
This trial has been identified as being associated with a clinical device that has not been
approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law
110-85, Title VIII, Section 801, the details of this study are not available to the public.
Sponsor:
[Redacted]
Information provided by:
[Redacted]
ClinicalTrials.gov Identifier:
NCT01650831
First received: July 24, 2012
Last updated: January 23, 2013
Last verified: NA
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 24, 2012 |
| Last Updated Date | January 23, 2013 |
| Start Date ICMJE | October 2012 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE |
The primary study endpoint is the dichotomous outcome agreement in diagnosis (presence/ absence of H. pylori) between the Modified BreathID and the currently approved BreathID® System. [ Time Frame: 25 minutes ] [ Designated as safety issue: No ] The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes. |
| Change History | Complete list of historical versions of study NCT01650831 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | [Trial of device that is not approved or cleared by the U.S. FDA] |
| Official Title ICMJE | [Trial of device that is not approved or cleared by the U.S. FDA] |
| Brief Summary | Not Provided |
| Detailed Description | Not Provided |
| Study Type ICMJE | Not Provided |
| Study Phase | Not Provided |
| Study Design ICMJE | Not Provided |
| Condition ICMJE | Not Provided |
| Intervention ICMJE | Not Provided |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Withheld |
| Enrollment ICMJE | Not Provided |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Not Provided |
| Gender | Not Provided |
| Ages | Not Provided |
| Accepts Healthy Volunteers | Not Provided |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01650831 |
| Other Study ID Numbers ICMJE | HP-MBI-0212 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | [Redacted] |
| Study Sponsor ICMJE | [Redacted] |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | [Redacted] |
| Verification Date | Not Provided |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|