Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
NCT01472172 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2013-12-05
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.
Conditions
- Pleural Effusion
- Pleural Diseases
Interventions
- 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.
Sponsors & Collaborators
-
The University Clinic of Pulmonary and Allergic Diseases Golnik
lead OTHER
Principal Investigators
-
Ales Rozman, MD · University Clinic Golnik
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2013-11-30
- Completion
- 2013-11-30
Countries
- Slovenia
Study Locations
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