Trial Outcomes & Findings for Tracking Renal Tumors After Cryoablation Evaluation (NCT NCT01117779)
NCT ID: NCT01117779
Last Updated: 2024-01-19
Results Overview
Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
Recruitment status
TERMINATED
Target enrollment
246 participants
Primary outcome timeframe
Baseline and months 6, 12, 24, 36, 48 and 60
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
Cryoablation
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants out of that 145 participants had lesion biopsy with proven Renal Cell Carcinoma (RCC).
|
|---|---|
|
Overall Study
STARTED
|
246
|
|
Overall Study
COMPLETED
|
246
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tracking Renal Tumors After Cryoablation Evaluation
Baseline characteristics by cohort
| Measure |
Cryoablation
n=246 Participants
Participants with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
156 Participants
n=5 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
246 participants
n=5 Participants
|
|
Lesion Size
|
2.5 cm
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
General Health
|
47.750 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Physical Functioning
|
49.190 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Role Physical
|
49.000 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Bodily Pain
|
48.710 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Vitality
|
49.070 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Social Functioning
|
48.010 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Mental Health
|
52.740 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Role Emotional
|
56.280 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Physical Component Summary
|
46.930 score on a scale
n=5 Participants
|
|
Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM
Mental Component Summary
|
52.72 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and months 6, 12, 24, 36, 48 and 60Population: Participants for whom cryoablation via GALIL Medical Cryoablation system was performed with available data at the respective time point.
Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
Outcome measures
| Measure |
Cryoablation
n=252 lesions
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Changes in Lesion Size
Baseline
|
2.5 cm
Interval 2.0 to 3.1
|
—
|
|
Changes in Lesion Size
Month 6
|
-0.2 cm
Interval -0.7 to 0.4
|
—
|
|
Changes in Lesion Size
Month 12
|
-0.4 cm
Interval -0.9 to -0.1
|
—
|
|
Changes in Lesion Size
Month 24
|
-0.8 cm
Interval -1.6 to -0.2
|
—
|
|
Changes in Lesion Size
Month 36
|
-1.0 cm
Interval -1.8 to -0.5
|
—
|
|
Changes in Lesion Size
Month 48
|
-1.0 cm
Interval -1.7 to -0.4
|
—
|
|
Changes in Lesion Size
Month 60
|
-1.0 cm
Interval -1.8 to -0.4
|
—
|
PRIMARY outcome
Timeframe: Baseline and months 6, 12, 24, 36, 48 and 60Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Renal Function Status
Baseline
|
64.9 ml/min
Interval 50.6 to 81.8
|
—
|
|
Renal Function Status
Month 6
|
60.3 ml/min
Interval 48.3 to 78.3
|
—
|
|
Renal Function Status
Month 12
|
59.75 ml/min
Interval 47.5 to 73.7
|
—
|
|
Renal Function Status
Month 24
|
59.72 ml/min
Interval 42.3 to 75.3
|
—
|
|
Renal Function Status
Month 36
|
57.51 ml/min
Interval 43.3 to 73.4
|
—
|
|
Renal Function Status
Month 48
|
59.50 ml/min
Interval 47.0 to 70.5
|
—
|
|
Renal Function Status
Month 60
|
60.00 ml/min
Interval 43.9 to 74.5
|
—
|
PRIMARY outcome
Timeframe: Average duration of 2 days or longerLength of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Hospital Stay
|
29.3 hours
Interval 25.8 to 34.1
|
—
|
PRIMARY outcome
Timeframe: Months 6, 12, 24, 36, 48 and 60Population: Lesion recurrence with enhancement
Lesions with imaging that showed contrast enhancement based on investigator assessment.
Outcome measures
| Measure |
Cryoablation
n=248 lesions
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 6
|
4 lesions
|
—
|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 12
|
3 lesions
|
—
|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 24
|
4 lesions
|
—
|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 36
|
1 lesions
|
—
|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 48
|
4 lesions
|
—
|
|
Post-cryoablation Lesion Recurrence With Enhancement
Month 60
|
1 lesions
|
—
|
PRIMARY outcome
Timeframe: Month 60Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Disease-specific Survival Rates
Alive
|
221 Participants
|
—
|
|
Disease-specific Survival Rates
Death due to other causes
|
25 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 60Death due to any cause
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Overall Survival Rates
Not censored (death)
|
25 Participants
|
—
|
|
Overall Survival Rates
Censored
|
221 Participants
|
—
|
PRIMARY outcome
Timeframe: Months 6 and 12QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7
Outcome measures
| Measure |
Cryoablation
n=234 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Quality of Life Assessment
Vitality at month 12
|
49.070 score on a scale
Interval 39.23 to 58.9
|
—
|
|
Quality of Life Assessment
Social Functioning at month 12
|
48.010 score on a scale
Interval 39.11 to 56.9
|
—
|
|
Quality of Life Assessment
Mental Health at month 6
|
52.740 score on a scale
Interval 41.26 to 58.47
|
—
|
|
Quality of Life Assessment
Mental Health at month 12
|
52.740 score on a scale
Interval 41.26 to 58.47
|
—
|
|
Quality of Life Assessment
Role Emotional at month 6
|
51.080 score on a scale
Interval 40.69 to 56.28
|
—
|
|
Quality of Life Assessment
Role Emotional at month 12
|
51.080 score on a scale
Interval 35.49 to 56.28
|
—
|
|
Quality of Life Assessment
Physical Component Summary at month 6
|
44.990 score on a scale
Interval 35.49 to 54.26
|
—
|
|
Quality of Life Assessment
Physical Component Summary at month 12
|
45.690 score on a scale
Interval 37.69 to 56.64
|
—
|
|
Quality of Life Assessment
Mental Component summary at month 6
|
52.720 score on a scale
Interval 44.11 to 57.53
|
—
|
|
Quality of Life Assessment
Mental Component summary at month 12
|
52.320 score on a scale
Interval 43.64 to 57.38
|
—
|
|
Quality of Life Assessment
General Health at month 6
|
47.750 score on a scale
Interval 33.84 to 57.69
|
—
|
|
Quality of Life Assessment
General Health at month 12
|
47.750 score on a scale
Interval 33.84 to 57.69
|
—
|
|
Quality of Life Assessment
Physical Functioning at month 6
|
41.320 score on a scale
Interval 33.45 to 57.06
|
—
|
|
Quality of Life Assessment
Physical Functioning at month 12
|
49.190 score on a scale
Interval 41.32 to 57.06
|
—
|
|
Quality of Life Assessment
Role Physical at month 6
|
44.770 score on a scale
Interval 40.54 to 57.46
|
—
|
|
Quality of Life Assessment
Role Physical at month 12
|
49.000 score on a scale
Interval 40.54 to 57.46
|
—
|
|
Quality of Life Assessment
Bodily Pain at month 6
|
48.710 score on a scale
Interval 39.69 to 57.73
|
—
|
|
Quality of Life Assessment
Bodily Pain at month 12
|
48.710 score on a scale
Interval 39.69 to 57.73
|
—
|
|
Quality of Life Assessment
Vitality at month 6
|
49.070 score on a scale
Interval 39.23 to 58.9
|
—
|
|
Quality of Life Assessment
Social Functioning at month 6
|
48.010 score on a scale
Interval 39.11 to 56.9
|
—
|
PRIMARY outcome
Timeframe: Month 60Time between cryotherapy and first evidence of metastatic disease
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Development of Metastatic Disease.
|
18.7 months
Interval 10.0 to 44.8
|
—
|
PRIMARY outcome
Timeframe: Month 60Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Total Number of Recurrences
|
18 recurrence
|
—
|
SECONDARY outcome
Timeframe: During the procedure and immediately after it, an average of 2 hours.Population: Participants treated with laparoscopic, percutaneous, or open procedure.
An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
n=145 Participants
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Procedure Method Outcomes
Number of freeze/thaw cycles=3
|
12 participants
|
9 participants
|
|
Procedure Method Outcomes
Number of freeze/thaw cycles=4
|
5 participants
|
2 participants
|
|
Procedure Method Outcomes
Complications (malfunction of cryoablation system)
|
3 participants
|
3 participants
|
|
Procedure Method Outcomes
Procedure Method: Laparoscopic
|
99 participants
|
63 participants
|
|
Procedure Method Outcomes
Procedure Method: Percutaneous
|
146 participants
|
81 participants
|
|
Procedure Method Outcomes
Procedure Method: Open
|
1 participants
|
1 participants
|
|
Procedure Method Outcomes
Number of lesions treated with cryoablation is One
|
242 participants
|
144 participants
|
|
Procedure Method Outcomes
Number of lesions treated with cryoablation is Two
|
2 participants
|
1 participants
|
|
Procedure Method Outcomes
Number of lesions treated with cryoablation is Three
|
2 participants
|
0 participants
|
|
Procedure Method Outcomes
Type of hemostatic agents or maneuvers used is None
|
154 participants
|
85 participants
|
|
Procedure Method Outcomes
Type of hemostatic agents or maneuvers used=Compression
|
6 participants
|
3 participants
|
|
Procedure Method Outcomes
Type of hemostatic agents or maneuvers used=Suturing
|
4 participants
|
2 participants
|
|
Procedure Method Outcomes
Type of hemostatic agents or maneuvers used=Floseal
|
74 participants
|
48 participants
|
|
Procedure Method Outcomes
Type of hemostatic agens or maneuvers used=Surgical
|
79 participants
|
52 participants
|
|
Procedure Method Outcomes
Type of hemostatic agents or maneuversed used=Other
|
2 participants
|
2 participants
|
|
Procedure Method Outcomes
Method of monitoring iceball formation=CT
|
145 participants
|
80 participants
|
|
Procedure Method Outcomes
Method of monitoring iceball formation=Ultrasound
|
100 participants
|
64 participants
|
|
Procedure Method Outcomes
Number of freeze/thaw cycles=0*
|
1 participants
|
1 participants
|
|
Procedure Method Outcomes
Number of freeze/thaw cycles=2
|
228 participants
|
133 participants
|
|
Procedure Method Outcomes
Intra-operative patient complications
|
13 participants
|
9 participants
|
SECONDARY outcome
Timeframe: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedurePopulation: Is participant disease free (renal specific?) Are there new therapies for renal cancer (patient specific)
Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
Outcome measures
| Measure |
Cryoablation
n=246 Participants
Patient with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.
There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).
|
RENAL CELL CARCINOMA (RCC) POPULATION
n=145 Participants
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).
|
|---|---|---|
|
Standard of Care Follow-up Procedures
New thereapies for renal cancer (patient specific)=No
|
121 participants
|
67 participants
|
|
Standard of Care Follow-up Procedures
Disease free=Yes
|
114 participants
|
61 participants
|
|
Standard of Care Follow-up Procedures
Disease free=No
|
8 participants
|
7 participants
|
|
Standard of Care Follow-up Procedures
Disease free=Indeterminate
|
2 participants
|
2 participants
|
|
Standard of Care Follow-up Procedures
New therapies for renal cancer (patient specific)=Yes
|
4 participants
|
4 participants
|
|
Standard of Care Follow-up Procedures
New therapies for renal cancer (patient specific)=Yes [Local]
|
4 participants
|
4 participants
|
|
Standard of Care Follow-up Procedures
New therapies for renal cancer (patient specific)=Yes [Systemic]
|
0 participants
|
0 participants
|
Adverse Events
Kidney Lesions Amenable to Cryoablation [ITT Population]
Serious events: 11 serious events
Other events: 33 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Kidney Lesions Amenable to Cryoablation [ITT Population]
n=246 participants at risk
Kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT patients with 145 patients having lesions biopsied and proven Renal Cell Carcinoma (RCC).
|
|---|---|
|
Surgical and medical procedures
BLEEDING/HEMORRHAGE, GU
|
0.81%
2/246 • Number of events 2 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Cardiac disorders
ARRHYTHMIA-SUPRAVENTRICULAR
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Surgical and medical procedures
HEMATOMA
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
General disorders
INFECTION (DOCUMENTED CLINICALLY) WITH GRADE 3 OR 4 ANC
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
General disorders
PAIN
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
RENAL HEMORRHAGE
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
STRICTURE OF THE COLLECTION SYSTEM OR URETERS/STRICTURE/STENOSIS
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
General disorders
OTHER
|
0.81%
2/246 • Number of events 2 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
Other adverse events
| Measure |
Kidney Lesions Amenable to Cryoablation [ITT Population]
n=246 participants at risk
Kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT patients with 145 patients having lesions biopsied and proven Renal Cell Carcinoma (RCC).
|
|---|---|
|
General disorders
OTHER
|
4.1%
10/246 • Number of events 10 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
General disorders
PAIN
|
2.8%
7/246 • Number of events 7 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Surgical and medical procedures
HEMATOMA
|
2.4%
6/246 • Number of events 6 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
CREATININE ELEVATION
|
1.6%
4/246 • Number of events 4 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
URINARY RETENTION/OLIGURIA
|
1.6%
4/246 • Number of events 4 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
BLEEDING/HEMORRHAGE, GU
|
0.81%
2/246 • Number of events 2 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
General disorders
VOMITING
|
0.81%
2/246 • Number of events 2 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Cardiac disorders
ARRHYTHMIA-SUPRAVENTRICULAR
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Gastrointestinal disorders
BLEEDING/HEMORRHAGE, GI
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Vascular disorders
HYPERTENSION
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
|
Renal and urinary disorders
RENAL HEMORRHAGE
|
0.41%
1/246 • Number of events 1 • Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
|
Additional Information
Chantal Laframboise, Clinical Research Manager
Boston Scientific
Phone: 613-882-0876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Per the Boston Scientific (BSCI) Clinical Trial Agreement, BSCI needs to publish first. PIs may publish their own data one year after the study has completed. If the PI wishes to publish after BSCI, then BSCI needs to be acknowledged in the publication.
- Publication restrictions are in place
Restriction type: OTHER