At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Cryoprobe biopsy +1 moredevice
Likely dose
Not stated in record
Key inclusion· 2
- ✓Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy
- ✓Pulmonary nodules of 8-50mm in largest dimension
Key exclusion· 6
- ✕Known bleeding diathesis or platelet count <50,000
- ✕Current use of systemic anticoagulation or antiplatelet therapy without ability to hold therapy for recommended time prior to procedure (aspirin monotherapy acceptable)
- ✕Pulmonary hypertension (RVSP >50 mmHg)
- ✕INR <1.5
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
In Brief
A clinical study evaluating Cryoprobe biopsy and Forceps biopsy for Bronchi--Diseases and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass
CountriesUnited States
CollaboratorsErbe USA Incorporated
Timeline
N/ACompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartAug 2022
Primary CompletionJul 2023
TodayJul 2026
First PostedJun 1, 2022
Enrollment StartAug 15, 2022
Primary CompletionJul 11, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.1 years ago
Interventions
Cryoprobe biopsydevice
A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Forceps biopsyprocedure
Biopsy forceps used to collect tissue