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Trial Outcomes & Findings for Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection (NCT NCT02528721)

NCT ID: NCT02528721

Last Updated: 2022-12-20

Results Overview

Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

282 participants

Primary outcome timeframe

9 months

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure
Initial Diagnosis Subjects
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Overall Study
STARTED
203
79
Overall Study
COMPLETED
196
76
Overall Study
NOT COMPLETED
7
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Initial Diagnosis Subjects
n=196 Participants
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
n=76 Participants
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Total
n=272 Participants
Total of all reporting groups
Age, Continuous
48.5 years
STANDARD_DEVIATION 14.94 • n=5 Participants
49.0 years
STANDARD_DEVIATION 15.53 • n=7 Participants
48.64 years
STANDARD_DEVIATION 15.11 • n=5 Participants
Sex: Female, Male
Female
116 Participants
n=5 Participants
48 Participants
n=7 Participants
164 Participants
n=5 Participants
Sex: Female, Male
Male
80 Participants
n=5 Participants
28 Participants
n=7 Participants
108 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.

Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result

Outcome measures

Outcome measures
Measure
Initial Diagnosis Subjects
n=179 Participants
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
n=68 Participants
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
98.32 Percent positive agreement
Interval 95.18 to 99.65
98.53 Percent positive agreement
Interval 92.08 to 99.96

PRIMARY outcome

Timeframe: 9 months

Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.

Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result

Outcome measures

Outcome measures
Measure
Initial Diagnosis Subjects
n=179 Participants
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
n=68 Participants
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
97.9 Percent negative agreement
Interval 93.99 to 99.57
100 Percent negative agreement
Interval 93.51 to 100.0

PRIMARY outcome

Timeframe: 9 months

Population: According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.

Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result

Outcome measures

Outcome measures
Measure
Initial Diagnosis Subjects
n=179 Participants
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
n=68 Participants
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
98.33 Percent overall agreement
Interval 95.21 to 99.65
100 Percent overall agreement
Interval 94.72 to 100.0

Adverse Events

Initial Diagnosis Subjects

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Post Therapy Subjects

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Initial Diagnosis Subjects
n=203 participants at risk
Patients with clinical indication for H.pylori infection Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Post Therapy Subjects
n=79 participants at risk
Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
Gastrointestinal disorders
Cyst
0.49%
1/203 • Number of events 1
0.00%
0/79
Gastrointestinal disorders
Gastric ulcer
0.49%
1/203 • Number of events 1
0.00%
0/79
General disorders
Nausea
0.99%
2/203 • Number of events 2
0.00%
0/79
General disorders
Lightheadedness
0.00%
0/203
1.3%
1/79 • Number of events 1

Additional Information

VP of Clinical Affairs

Exalenz Bioscience

Phone: 972-8-9737502

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60