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Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

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ClinicalTrials.gov Identifier: NCT01650831
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : September 2, 2013
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Condition Suspicion of Being Infected With H.Pylori
Intervention Device: Modified BreathID
Enrollment 113
Recruitment Details Adult subjects with suspected infection of Helicobacter Pylori due to symptoms were offered to do the test on a walk- in basis were recruited. 113 Subjects were recruited in October and November 2012 in a private medical clinic.
Pre-assignment Details Subjects with prior knowledge of Helicobacter Pylori infection or taking proton pump inhibitors within the two week period before the test, were not included.Only one test per subject was done.
Arm/Group Title Clinical Suspicion of Hpylori
Hide Arm/Group Description

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Period Title: Overall Study
Started 113
Completed 112
Not Completed 1
Reason Not Completed
Screen failure             1
Arm/Group Title Clinical Suspicion of Hpylori
Hide Arm/Group Description

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
<=18 years
0
   0.0%
Between 18 and 65 years
90
  79.6%
>=65 years
23
  20.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants
49.6  (16.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Female
60
  53.1%
Male
53
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 113 participants
113
1.Primary Outcome
Title Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori
Hide Description 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.
Time Frame 25 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).
Arm/Group Title Clinical Suspicion of Hpylori
Hide Arm/Group Description:

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Positive agreeement
100
(81.57 to 100)
Negative agreement
96.8
(88.98 to 99.11)
2.Primary Outcome
Title Positive/Negative for H.Pylori With Cleared BreathID
Hide Description The amount of subjects that produced positive/negative results with cleared BreathID device
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol positive/negative when testing with marketed BreathID
Arm/Group Title Marketed BreathID Positive Marketed BreathID Negative
Hide Arm/Group Description:
Cleared BreathID subjects that were found to be positive for H.pylori
Cleared BreathID subjects that were found to be negative for H.pylori
Overall Number of Participants Analyzed 79 79
Measure Type: Number
Unit of Measure: participants
17 62
3.Primary Outcome
Title Positive/Negative for H.Pylori With Modified BreathID
Hide Description The amount of subjects that produced positive/negative results for H.pylori with modified BreathID
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol subjects tested with modified BreathID
Arm/Group Title Positive Modified BreathID Negative Modified BreathID
Hide Arm/Group Description:
The amount of subjects that produced positive results for H.pylori with modified BreathID.
The amount of subjects that produced negative results for H.pylori with modified BreathID.
Overall Number of Participants Analyzed 79 79
Measure Type: Number
Unit of Measure: participants
19 60
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinical Suspicion of Hpylori
Hide Arm/Group Description

All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions

Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula

All-Cause Mortality
Clinical Suspicion of Hpylori
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clinical Suspicion of Hpylori
Affected / at Risk (%)
Total   0/113 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinical Suspicion of Hpylori
Affected / at Risk (%)
Total   0/113 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Avraham Hershkowitz, Clinical Trials Manager
Organization: Exalenz.Bioscience Ltd.
Phone: +972-8-9737513
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01650831     History of Changes
Other Study ID Numbers: HP-MBI-0212
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: May 28, 2013
Results First Posted: September 2, 2013
Last Update Posted: April 15, 2016