A Pilot Study Evaluating a Novel Minimally Invasive String-test and Rapid Antigen Assay for Helicobacter Pylori Detection
Sponsor study identifier
interventional
40
1 country
1
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This single-center, open-label, prospective pilot study aims to evaluate the feasibility, safety, and preliminary diagnostic performance of a minimally invasive gastric string sampling device combined with a rapid antigen assay for the detection of Helicobacter pylori infection. A total of 40 participants with documented \^13C-urea breath test (UBT) results will be enrolled, including 30 UBT-positive and 10 UBT-negative participants. All participants will undergo gastric mucus collection using a disposable string sampling device, followed by H. pylori rapid antigen testing. The primary objective is to assess the diagnostic sensitivity and specificity of the investigational test using \^13C-UBT as the reference standard. The secondary objective is to explore the correlation between the semi-quantitative test-line (T-line) color intensity of the rapid antigen assay and the corresponding UBT delta-over-baseline (DOB) values.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2026
Actual (reported)October 30, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diagnostic Sensitivity and Specificity of the HP String Test With Rapid Antigen Assay
Diagnostic sensitivity and specificity of the gastric string test combined with a rapid antigen assay for detecting Helicobacter pylori infection, using the \^13C-urea breath test (UBT) as the reference standard (DOB ≥4.0 indicating a positive result and DOB \<4.0 indicating a negative result).
At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Correlation Between T-Line Color Intensity and ^13C-UBT DOB Values
At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Gastric mucus collection using a minimally invasive string test followed by Helicobacter pylori rapid antigen testing. The investigational test results will be compared with the participants' existing \^13C-UBT results as the reference standard to evaluate diagnostic agreement and preliminary diagnostic accuracy.
Fu Jen Catholic University Hospital
New Taipei City, Taiwan, 24352, Taiwan
First Submitted
October 25, 2026
First Posted
October 30, 2026
Study Start
Feasibility Study of Phototherapy System to Treat H Pylori
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December 2026
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
Individual participant data (IPD) will not be shared with external researchers to protect participant confidentiality and comply with institutional data protection policies. Only aggregated study results and findings published in scientific journals will be made available.
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Source: ClinicalTrials.gov.
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