Trial Outcomes & Findings for The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS) (NCT NCT02323854)
NCT ID: NCT02323854
Last Updated: 2018-05-07
Results Overview
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
1 Day
Results posted on
2018-05-07
Participant Flow
Participant milestones
| Measure |
Ablation and Surgical Resection
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data was collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Baseline characteristics by cohort
| Measure |
Ablation and Surgical Resection
n=15 Participants
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Age, Customized
Age
|
58.9 Years
STANDARD_DEVIATION 15.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
Outcome measures
| Measure |
Ablation and Surgical Resection
n=11 Participants
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Dose Response
% Change Ablation Zone Width (X)
|
-43.6 percent difference
Standard Deviation 18.8
|
|
Dose Response
% Change Ablation Zone Height (Y)
|
-15.1 percent difference
Standard Deviation 31.7
|
|
Dose Response
% Change Ablation Zone Depth (Z)
|
-32.8 percent difference
Standard Deviation 26.0
|
|
Dose Response
% Change (Actual Volume vs Predicted Volume)
|
-63.5 percent difference
Standard Deviation 26.3
|
|
Dose Response
% Change (Actual Calculated Vol. vs Predicted)
|
-57.7 percent difference
Standard Deviation 31.8
|
PRIMARY outcome
Timeframe: Same dayPopulation: Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Outcome measures
| Measure |
Ablation and Surgical Resection
n=11 Participants
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Ablation Zone Shape
|
0.6 Ratio
Standard Deviation .2
|
SECONDARY outcome
Timeframe: Same DayPopulation: Secondary endpoint results were available for 11 subjects. For the secondary results, there were no tumors in four out of 15 samples (26.6%). Therefore, assessment of tumor cannot be made.
The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.
Outcome measures
| Measure |
Ablation and Surgical Resection
n=11 Participants
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Number of Participants With Complete or Incomplete Tumor Ablation
Incomplete Ablation
|
4 Participants
|
|
Number of Participants With Complete or Incomplete Tumor Ablation
Delayed Necrosis
|
1 Participants
|
|
Number of Participants With Complete or Incomplete Tumor Ablation
Complete Ablation
|
6 Participants
|
Adverse Events
Ablation and Surgical Resection
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ablation and Surgical Resection
n=15 participants at risk
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.7%
1/15 • Number of events 1 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
6.7%
1/15 • Number of events 1 • 30 Days Post-procedure.
|
|
Nervous system disorders
Guillain Barre Syndrome
|
6.7%
1/15 • Number of events 1 • 30 Days Post-procedure.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
6.7%
1/15 • Number of events 1 • 30 Days Post-procedure.
|
Other adverse events
| Measure |
Ablation and Surgical Resection
n=15 participants at risk
All subjects meeting the inclusion/exclusion criteria were enrolled into the study to receive microwave ablation from the Emprint™ Ablation System using a percutaneous approach in patients with metastatic or primary lung tumors.
Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
Once the ablation procedure was completed, the scheduled surgical tumor resection was performed. Adverse event data were collected starting from the initial administration of anesthesia until conclusion of the first post-operative follow-up visit.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
40.0%
6/15 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
26.7%
4/15 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
13.3%
2/15 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
6.7%
1/15 • 30 Days Post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.7%
1/15 • 30 Days Post-procedure.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • 30 Days Post-procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place