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Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

NCT05230992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-02-14

No results posted yet for this study

Summary

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.

There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.

The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

Conditions

  • Nodule

Interventions

DEVICE

Cryoprobes First

In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.

DEVICE

Cryoprobes Second

In this second experimental group, the same medical devices are used but in the other order.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-05
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • France

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 NCT05230992 on ClinicalTrials.gov