Trial Outcomes & Findings for Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection (NCT NCT01650831)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

113 participants

Primary outcome timeframe

25 minutes

Results posted on

2022-12-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Clinical Suspicion of Hpylori 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 Study STARTED	113
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical Suspicion of Hpylori 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 Study Screen failure	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Suspicion of Hpylori n=113 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 16.71 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment United States	113 participants n=5 Participants

PRIMARY outcome

Timeframe: 25 minutes

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Clinical Suspicion of Hpylori n=79 Participants 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	Marketed BreathID Negative Cleared BreathID subjects that were found to be negative for H.pylori
Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori Positive agreeement	100 Percentage of participants Interval 81.57 to 100.0	—
Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori Negative agreement	96.8 Percentage of participants Interval 88.98 to 99.11	—

PRIMARY outcome

Timeframe: 1 hour

Population: Per protocol positive/negative when testing with marketed BreathID

The amount of subjects that produced positive/negative results with cleared BreathID device

Outcome measures

Outcome measures
Measure	Clinical Suspicion of Hpylori n=79 Participants 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	Marketed BreathID Negative n=79 Participants Cleared BreathID subjects that were found to be negative for H.pylori
Positive/Negative for H.Pylori With Cleared BreathID	17 participants	62 participants

PRIMARY outcome

Timeframe: 1 hour

Population: Per protocol subjects tested with modified BreathID

The amount of subjects that produced positive/negative results for H.pylori with modified BreathID

Outcome measures

Outcome measures
Measure	Clinical Suspicion of Hpylori n=79 Participants 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	Marketed BreathID Negative n=79 Participants Cleared BreathID subjects that were found to be negative for H.pylori
Positive/Negative for H.Pylori With Modified BreathID	19 participants	60 participants

Adverse Events

Clinical Suspicion of Hpylori

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Avraham Hershkowitz, Clinical Trials Manager

Exalenz.Bioscience Ltd.

Phone: +972-8-9737513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place