Health Condition 1: K319- Disease of stomach and duodenum, unspecified
Conditions
Interventions
Intervention1: PYtest® Urea [14 C] Capsule: Urea breath test using urea[14C] capsule of the PYtest® Kit.
To detect H. pylori, urea labelled with 14C is swallowed by the patient. If gastric urease from
Sponsors
Tri-Med Distributors Pty Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients who present with clinical symptoms of H. pylori Have the ability and willingness to sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patient with current serious underlying disease. Participation in other trials currently. Patients who have been taking or have taken antibiotics and/or bismuth preparations for (4) weeks prior to test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of PYtest® (urea[14C] breath test) kit in comparison to Rapid urease diagnostic test.Timepoint: The diagnostic tests will be performed during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening). Visit 2 will include the following procedures: • Endoscopy and Rapid Urease Test • PYtest® (urea[14C] capsule) administration and Urea breath analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Urea[14C] capsule of PYtest ® KitTimepoint: The safety will be evaluated during Visit 2, which should be scheduled within 3 days of Visit 1 (Screening), & at the end of the study (follow up period), that is within 3 days of the Visit 2 . | — |
Countries
India
Contacts
Public ContactDr Vimla Dsouza
Arcolab Private Limited
Outcome results
None listed