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Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD

NCT02456779 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1032

Last updated 2017-12-08

No results posted yet for this study

Summary

The primary objective of this clinical study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic methods commonly applied in clinical practice by testing a large number of clinical samples.

This will be performed by evaluating Peptest results in GERD patients (Erosive esophagitis or NERD), defined using standard clinical procedures, and compared to healthy controls.

Conditions

  • Gastro-esophageal Reflux Disease

Interventions

OTHER

in vitro diagnostic test (Peptest)

saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest

OTHER

Questionnaire

all recruited subjects to complete the RDQ as a determinant of inclusion criteria

OTHER

Questionnaire

control subjects to complete RSI as a determinant of inclusion criteria

Sponsors & Collaborators

  • RD Biomed Ltd

    collaborator UNKNOWN

  • MAAB (Shanghai) Medical Device Limited

    lead INDUSTRY

Principal Investigators

  • Jing-Yuan Fang · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-01-31
Completion
2017-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456779 on ClinicalTrials.gov