NCT01472172

Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

Detailed description

The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Conditions

• Pleural Effusion
• Pleural Diseases

Interventions

Type	Name	Description
DEVICE	Cryobiopsy (Autoclavable cryoprobe 20416-032)	The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-11-16
• Last updated: 2013-12-05

Locations

1 site across 1 country: Slovenia