Trial Outcomes & Findings for A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) (NCT NCT01101958)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

30 Days

Results posted on

2017-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm--CV Negative This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.	Treatment Arm--CV Positive This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
Overall Study STARTED	62	34
Overall Study COMPLETED	51	29
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm--CV Negative n=62 Participants This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.	Treatment Arm--CV Positive n=34 Participants This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.	Total n=96 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 9 • n=7 Participants	63 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	19 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	15 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment Netherlands	21 participants n=5 Participants	9 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Germany	34 participants n=5 Participants	23 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment Sweden	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: Per protocol population analyzed \[16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes\].

Outcome measures

Outcome measures
Measure	Treatment Arm--CV Negative n=51 Participants This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.	Treatment Arm--CV Positive n=29 Participants This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
Lung Volume Change	56 percent decrease in lung volume Interval 18.0 to 92.0	6 percent decrease in lung volume Interval 2.0 to 16.0

Adverse Events

Treatment Arm--CV Negative

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Arm--CV Positive

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm--CV Negative n=51 participants at risk This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.	Treatment Arm--CV Positive n=29 participants at risk This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.8% 4/51 • Number of events 4	6.9% 2/29 • Number of events 2
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	2.0% 1/51 • Number of events 1	10.3% 3/29 • Number of events 3
Respiratory, thoracic and mediastinal disorders Pneumonia	2.0% 1/51 • Number of events 1	0.00% 0/29

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. F.J.F. Herth

ThoraxKlinik, University of Heidelberg

Phone: 650-216-0176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60