Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorElisabethinen Hospital

About this trial

In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.

Eligibility criteria

Qualifiers

Solitary nodule ≤ 2.5 cm

Candidate for diagnostic bronchoscopy & LN staging

Eligible for surgical resection

Histologically proven lung cancer

Disqualifiers

Pregnancy/nursing

central tumours abutting vital structures

thoracic electronic implants

uncorrectable coagulopathy or platelets ≤50 × 10⁹/L

Trial design

Treatments tested in this trial

  • Cryotherapy

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators