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Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)

NCT06193239 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-10-15

No results posted yet for this study

Summary

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups.

The contrast groups will be representative of the clinical populations in which the test is intended to be used.

Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.

Conditions

Interventions

DIAGNOSTIC_TEST

OWL-EVO1

EVOC probe

Sponsors & Collaborators

  • Owlstone Ltd

    lead INDUSTRY

Principal Investigators

  • Robert Rintoul · Royal Papworth Hospital NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-04-25
Completion
2025-04-30

Countries

  • Czechia
  • Hungary
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06193239 on ClinicalTrials.gov