A study to evaluate the efficacy of the fecal elastase-1 test kit in diagnosis for pancreatic exocrine insufficiency.

A study to evaluate the efficacy of the fecal elastase-1 (FE-1) test kit (provisional name) by immunochromatographic assay in diagnosis for pancreatic exocrine insufficiency. - Clinical performance test of FE-1 Quick test

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052453

Enrollment

164

Registered

2023-10-10

Start date

2023-10-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic exocrine insufficiency

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who consent to participate in this study, and patients that their legal representatives give consent on behalf of children in case that they are under 18 years of age.

Exclusion criteria

Exclusion criteria: Patients who judged ineligible by investigators

Design outcomes

Primary

Measure	Time frame
Positive concordance rate, negative concordance rate and total concordance rate of the results between ScheBo Pancreas Elastase 1 Quick test and the control assay	—

Secondary

Measure	Time frame
Not set.	—

Countries

Japan

Contacts

Public ContactTatsuro Saito

RIKEN Genesis Co., Ltd. Drug Development Support Office

RGK-fe1q@rikengenesis.jp03-5759-6041

Outcome results