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

• Sponsor: Exalenz Bioscience LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02528721
• Collaborator: (none)
• Enrollment: 282
• Locations: 13
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 21.7
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Device: Dual Mode BreathID Hp System	Phase 3

Detailed Description

Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.

Study Design

• Study Type: Interventional
• Actual Enrollment: 282 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Initial Diagnosis Subjects Patients with clinical indication for H.pylori infection	Device: 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; Other Names: Hp™ TWO Dual Mode BreathID® Hp
Experimental: Post Therapy Subjects Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months	Device: 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; Other Names: Hp™ TWO Dual Mode BreathID® Hp

Outcome Measures

Primary Outcome Measures

1. Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy [9 months]

   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

2. Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy [9 months]

   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

3. Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy [9 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age.

• Have the ability and willingness to sign the Informed Consent Form.

• Present with clinical indication of H. pylori and a candidate for upper endoscopy

For Initial Diagnosis arm:

• Symptomatic patients naïve to H.pylori treatment in the past 18 months

For Post-Therapy arm:

• Documented biopsy with positive outcome prior to eradication therapy (including method of determination)

• Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT

Exclusion Criteria:

• Participation in other interventional trials.

• Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.

• PPI or H2 blockers within two (2) weeks prior to breath test.

• Pregnant or breastfeeding women.

• Allergy to test substrates.

• Patient did not fast for the hour prior to the UBT

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Del Sol Research Management	Tucson	Arizona	United States	85710
2	Ventura Clinical Trials	Ventura	California	United States	93003
3	Innovative Clincal Research	Lafayette	Colorado	United States	80026
4	Palmetto Research	Hialeah	Florida	United States	33016
5	Hope Clinical Research	Kissimmee	Florida	United States	34741
6	Metropolitan Gastro Group	Chevy Chase	Maryland	United States	20815
7	Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center	Wyoming	Michigan	United States	49519
8	Digestive Disease Care	New Hyde Park	New York	United States	11040
9	Great Lakes Medical Research	Willoughby	Ohio	United States	44094
10	Innovative Clinical Research	Rapd City	South Dakota	United States	57701
11	Digestive Disease Center of South Texas, P.L.L.C	San Antonio	Texas	United States	78215
12	Barzilai Medical center	Ashkelon		Israel	7830604
13	Assaf Harofe Medical Center	Tzrifin		Israel	70300

Sponsors and Collaborators

• Exalenz Bioscience LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exalenz Bioscience LTD.
• ClinicalTrials.gov Identifier: NCT02528721
• Other Study ID Numbers: DM2-HP-0715
• First Posted: Aug 19, 2015
• Last Update Posted: Mar 3, 2017
• Last Verified: Nov 1, 2016

Study Results

Participant Flow

Arm/Group Title	Initial Diagnosis Subjects	Post Therapy Subjects
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	203	79
COMPLETED	196	76
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Initial Diagnosis Subjects	Post Therapy Subjects	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	196	76	272
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.5 (14.94)	49.0 (15.53)	48.64 (15.11)
Gender (Count of Participants)
Female	116 59.2%	48 63.2%	164 60.3%
Male	80 40.8%	28 36.8%	108 39.7%

Outcome Measures

1. Primary Outcome

Title	Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Description	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
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Initial Diagnosis Subjects	Post Therapy Subjects
Arm/Group Description	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	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
Measure Participants	179	68
Number (95% Confidence Interval) [Percent positive agreement]	98.32	98.53

2. Primary Outcome

Title	Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Description	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
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Initial Diagnosis Subjects	Post Therapy Subjects
Arm/Group Description	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	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
Measure Participants	179	68
Number (95% Confidence Interval) [Percent negative agreement]	97.9	100

3. Primary Outcome

Title	Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Description	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
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Initial Diagnosis Subjects	Post Therapy Subjects
Arm/Group Description	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	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
Measure Participants	179	68
Number (95% Confidence Interval) [Percent overall agreement]	98.33	100

Adverse Events

Arm/Group Title	Initial Diagnosis Subjects		Post Therapy Subjects
Arm/Group Description	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		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
All Cause Mortality
	Initial Diagnosis Subjects		Post Therapy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Initial Diagnosis Subjects		Post Therapy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/79 (0%)
Other (Not Including Serious) Adverse Events
	Initial Diagnosis Subjects		Post Therapy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/203 (2%)		1/79 (1.3%)
Gastrointestinal disorders
Cyst	1/203 (0.5%)	1	0/79 (0%)	0
Gastric ulcer	1/203 (0.5%)	1	0/79 (0%)	0
General disorders
Nausea	2/203 (1%)	2	0/79 (0%)	0
Lightheadedness	0/203 (0%)	0	1/79 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.