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

NCT01650831 | Completed Results DMC

• 1 other identifier: HP-MBI-0212
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

Conditions

Suspicion of Being Infected With H.Pylori

Keywords

Helicobacter Pylori; 13C Urea Breath Test; BreathID

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori

  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.

  25 minutes

• Positive/Negative for H.Pylori With Cleared BreathID

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

  1 hour

• Positive/Negative for H.Pylori With Modified BreathID

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

  1 hour

Study Arms (1)

Clinical Suspicion of Hpylori

ACTIVE COMPARATOR

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

Device: Modified BreathID

Interventions

Modified BreathID DEVICE

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

Also known as: BreathID Hp

Clinical Suspicion of Hpylori

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• Present with clinical indication of H. pylori
• Have the ability and willingness to sign the Informed Consent Form-

You may not qualify if:

• Current serious disease
• Participation in other trials
• Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
• PPI or H2 blockers for two (2) weeks prior to test
• Childbearing or breastfeeding women
• Based on opinion of investigator, subject should not be enrolled in this trial
• Allergy to citrus juice
• Post -eradication therapy for H. pylori

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (1)

Unimed Center

East Brunswick, New Jersey, 08816, United States

Location

Related Publications (1)

• Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29.

  PMID: 17608775 BACKGROUND

Results Point of Contact

• Title: Avraham Hershkowitz, Clinical Trials Manager
• Organization: Exalenz.Bioscience Ltd.

avrahamh@exalenz.com

+972-8-9737513

Study Officials

• Jenny Liu, MD

  Unimed Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 20, 2022
• Results First Posted: September 2, 2013

Record last verified: 2022-12

Locations

US (1)