Trial Outcomes & Findings for Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe (NCT NCT05399082)

Results Overview

Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Forceps Biopsy First, Then Research Cryoprobe Biopsy Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy first, then crossover to receive the research cryoprobe biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue	Research Cryoprobe Biopsy First, Then Standard Forceps Biopsy Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Research cryoprobe biopsy first, then crossover to receive the standard forceps biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue
First Intervention STARTED	15	15
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	15	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Forceps Biopsy First, Then Research Cryoprobe Biopsy n=15 Participants Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy first, then crossover to receive the research cryoprobe biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue	Research Cryoprobe Biopsy First, Then Standard Forceps Biopsy n=15 Participants Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Research cryoprobe biopsy first, then crossover to receive the standard forceps biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue	Total n=30 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 9.23 • n=5 Participants	70.2 years STANDARD_DEVIATION 7.11 • n=7 Participants	70.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Outcome measures

Outcome measures
Measure	Standard Forceps Biopsy n=30 Participants Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy: Biopsy forceps used to collect tissue	Research Cryoprobe Biopsy n=30 Participants Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Ability to Successfully Obtain Sample	123 tissue samples	130 tissue samples

SECONDARY outcome

Timeframe: Biopsy procedure, approximately 3 hours

Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.

Outcome measures

Outcome measures
Measure	Standard Forceps Biopsy n=30 Participants Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy: Biopsy forceps used to collect tissue	Research Cryoprobe Biopsy n=30 Participants Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Duration of Biopsy Procedure	41 minutes Interval 30.0 to 53.0	41 minutes Interval 21.0 to 54.0

SECONDARY outcome

Timeframe: Biopsy procedure, approximately 60 seconds

Population: This outcome measure was only collected and analyzed for the Research cryoprobe biopsy arm

Total freezing time for cryoprobe biopsies, measured in seconds

Outcome measures

Outcome measures
Measure	Standard Forceps Biopsy Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy: Biopsy forceps used to collect tissue	Research Cryoprobe Biopsy n=30 Participants Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Freezing Time for Cryoprobe Biopsies	—	4.54 seconds Standard Deviation 0.91

SECONDARY outcome

Timeframe: Biopsy procedure, approximately 3 hours

One attempt is defined as insertion of the biopsy probe into the robotic sheath, activation/employment of the biopsy mechanism at the target site and retrieval via the robotic sheath. A biopsy attempt is successful if a tissue sample that is considered by the bronchoscopist to be adequate for further pathological analysis can be retrieved.