Trial Outcomes & Findings for Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy (NCT NCT01986829)
NCT ID: NCT01986829
Last Updated: 2018-09-19
Results Overview
Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.
TERMINATED
PHASE2
9 participants
3 months
2018-09-19
Participant Flow
The study opened to participant enrollment on 02/03/2014 and closed to participant enrollment on 06/19/2017.
Participant milestones
| Measure |
Treatment (Ablation)
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Ablation)
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy
Baseline characteristics by cohort
| Measure |
Treatment (Ablation)
n=9 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDefined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.
Outcome measures
| Measure |
Treatment (Ablation)
n=8 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Progression-free Rate
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 5 years-Defined as time from diagnosis of metastatic disease to the time of death
Outcome measures
| Measure |
Treatment (Ablation)
n=9 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Overall Survival (OS)
|
23.6 months
Interval 5.1 to 44.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I have a lack of energy" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
Not at all (score = 0)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
A little bit (score = 1)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
Somewhat (score = 2)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
Quite a bit (score = 3)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
Very much (score = 4)
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I have nausea" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
Not at all (score = 0)
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
A little bit (score = 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
Somewhat (score = 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
Quite a bit (score = 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
Very much (score = 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I worry that my condition will get worse" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
Not at all (score = 0)
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
A little bit (score = 1)
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
Somewhat (score = 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
Quite a bit (score = 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
Very much (score = 4)
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. 1 participant did not complete this question on the survey at pre-treatment. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I am able to enjoy life" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=6 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
Not at all (score = 0)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
A little bit (score = 1)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
Somewhat (score = 2)
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
Quite a bit (score = 3)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
Very much (score = 4)
|
2 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I am sleeping well" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
Not at all (score = 0)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
A little bit (score = 1)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
Somewhat (score = 2)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
Quite a bit (score = 3)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
Very much (score = 4)
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I am content with the quality of my life right now" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
Not at all (score = 0)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
A little bit (score = 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
Somewhat (score = 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
Quite a bit (score = 3)
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
Very much (score = 4)
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was "I have pain" * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Outcome measures
| Measure |
Treatment (Ablation)
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Post-Treatment
n=7 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
Disease Progression
n=4 Participants
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|---|---|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
Not at all (score = 0)
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
A little bit (score = 1)
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
Somewhat (score = 2)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
Quite a bit (score = 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
Very much (score = 4)
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)Population: The data for this outcome measure was not collected as participant's pain was collected via the Fact G7 questionnaire.
Measured using the Brief Pain Inventory. Final assessment at time of disease progression. Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean BPI scores between any two times. All analyses will be two-sided at a significance level of 0.05.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ablation)
Serious adverse events
| Measure |
Treatment (Ablation)
n=9 participants at risk
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|
|
Blood and lymphatic system disorders
Intraoperative hemorrhage
|
11.1%
1/9 • Adverse event data was collected on the first day of ablation through 30 days following the completion of ablation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
33.3%
3/9 • Adverse event data was collected on the first day of ablation through 30 days following the completion of ablation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.1%
1/9 • Adverse event data was collected on the first day of ablation through 30 days following the completion of ablation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Adverse event data was collected on the first day of ablation through 30 days following the completion of ablation.
|
Other adverse events
| Measure |
Treatment (Ablation)
n=9 participants at risk
* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
11.1%
1/9 • Adverse event data was collected on the first day of ablation through 30 days following the completion of ablation.
|
Additional Information
Brian Van Tine, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place