Trial Outcomes & Findings for Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study (NCT NCT03578237)
NCT ID: NCT03578237
Last Updated: 2023-02-10
Results Overview
Measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
afternoon of postoperative day 2
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
ACTIVE Cryoneurolysis
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Postoperative Days 0-21
STARTED
|
51
|
48
|
|
Postoperative Days 0-21
COMPLETED
|
51
|
48
|
|
Postoperative Days 0-21
NOT COMPLETED
|
0
|
0
|
|
Postoperative Day 0 - Month 12
STARTED
|
51
|
48
|
|
Postoperative Day 0 - Month 12
COMPLETED
|
37
|
32
|
|
Postoperative Day 0 - Month 12
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
ACTIVE Cryoneurolysis
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Postoperative Day 0 - Month 12
Timepoints past 21 days were only for amputee and mastectomy subjects and not others
|
14
|
16
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment (Active Cryoneurolysis)
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
Sham
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 15 • n=51 Participants
|
52 years
STANDARD_DEVIATION 16 • n=48 Participants
|
51.5 years
STANDARD_DEVIATION 15.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=51 Participants
|
31 Participants
n=48 Participants
|
71 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=51 Participants
|
17 Participants
n=48 Participants
|
28 Participants
n=99 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
70.6 kilograms
STANDARD_DEVIATION 13.7 • n=51 Participants
|
68.8 kilograms
STANDARD_DEVIATION 14.8 • n=48 Participants
|
69.6 kilograms
STANDARD_DEVIATION 14.2 • n=99 Participants
|
|
Height
|
165.1 centimeters
STANDARD_DEVIATION 8.0 • n=51 Participants
|
165.7 centimeters
STANDARD_DEVIATION 7.6 • n=48 Participants
|
165.4 centimeters
STANDARD_DEVIATION 7.7 • n=99 Participants
|
|
Body Mass Index
|
25.9 kg/m^2
STANDARD_DEVIATION 4.6 • n=51 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 4.5 • n=48 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=99 Participants
|
PRIMARY outcome
Timeframe: afternoon of postoperative day 2Measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Average Pain (Mastectomy Subjects Only)
|
0.0 score on a scale
Interval 0.0 to 1.4
|
3.0 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, 21, as well as months 1, 3, 6, and 12Analgesic consumption for previous 24 hours
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Analgesic Consumption
Postoperative Day 14
|
0.2 tablets of oxycodone (5 mg tablets)
Standard Deviation 0.6
|
0.5 tablets of oxycodone (5 mg tablets)
Standard Deviation 1.3
|
|
Analgesic Consumption
Postoperative Day 1
|
1.2 tablets of oxycodone (5 mg tablets)
Standard Deviation 2.3
|
3.3 tablets of oxycodone (5 mg tablets)
Standard Deviation 4.5
|
|
Analgesic Consumption
Postoperative Day 2
|
1.0 tablets of oxycodone (5 mg tablets)
Standard Deviation 1.6
|
4.1 tablets of oxycodone (5 mg tablets)
Standard Deviation 3.8
|
|
Analgesic Consumption
Postoperative Day 3
|
.8 tablets of oxycodone (5 mg tablets)
Standard Deviation 1.9
|
3.2 tablets of oxycodone (5 mg tablets)
Standard Deviation 3.7
|
|
Analgesic Consumption
Postoperative Day 4
|
0.7 tablets of oxycodone (5 mg tablets)
Standard Deviation 1.5
|
2.7 tablets of oxycodone (5 mg tablets)
Standard Deviation 3.5
|
|
Analgesic Consumption
Postoperative Day 7
|
0.5 tablets of oxycodone (5 mg tablets)
Standard Deviation 1.2
|
1.5 tablets of oxycodone (5 mg tablets)
Standard Deviation 2.2
|
|
Analgesic Consumption
Postoperative Day 21
|
0.1 tablets of oxycodone (5 mg tablets)
Standard Deviation 0.5
|
0.3 tablets of oxycodone (5 mg tablets)
Standard Deviation 0.8
|
|
Analgesic Consumption
Postoperative Month 1
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
|
Analgesic Consumption
Postoperative Month 3
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
|
Analgesic Consumption
Postoperative Month 6
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
|
Analgesic Consumption
Postoperative Month 12
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
0 tablets of oxycodone (5 mg tablets)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
The Brief Pain Inventory short form (interference scale) is designed to assess pain's impact on physical and emotional functioning. It has established reliability and validity, with minimal inter-rater discordance, and is recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus statement. The interference domaine is comprised of 7 questions involving the degree of pain's interference on physical and emotional functioning using a 0-10 Likert scale (0 = none; 10 = complete). The scale is thus 0-70 with higher scores equivalent to more interference due to pain\>
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Brief Pain Inventory (Interference Subscale)
Month 3
|
0 units on a scale
Standard Deviation 0
|
0.6 units on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (Interference Subscale)
Month 1
|
0 units on a scale
Standard Deviation 0
|
4.1 units on a scale
Standard Deviation 9.2
|
|
Brief Pain Inventory (Interference Subscale)
Month 6
|
0 units on a scale
Standard Deviation 0
|
1.1 units on a scale
Standard Deviation 2.3
|
|
Brief Pain Inventory (Interference Subscale)
Month 12
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, and 21The subjects' perception of their worst level pain in the previous 24 hours measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 2
|
3.3 score on a scale
Standard Deviation 2.9
|
5.6 score on a scale
Standard Deviation 2.7
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 3
|
2.8 score on a scale
Standard Deviation 2.7
|
5.1 score on a scale
Standard Deviation 2.8
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 1
|
3.7 score on a scale
Standard Deviation 2.5
|
5.5 score on a scale
Standard Deviation 2.4
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 4
|
2.4 score on a scale
Standard Deviation 2.6
|
4.3 score on a scale
Standard Deviation 2.7
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 7
|
2.4 score on a scale
Standard Deviation 2.4
|
3.7 score on a scale
Standard Deviation 2.4
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 14
|
1.6 score on a scale
Standard Deviation 2.4
|
3.1 score on a scale
Standard Deviation 2.3
|
|
Worst Pain Measured on the 11 Point Numeric Rating Scale
Postoperative Day 21
|
1.4 score on a scale
Standard Deviation 2.6
|
3.0 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, and 21The subjects' perception of their average level pain in the previous 24 hours measured with the 0-10 numeric rating scale as part of the Brief Pain Inventory, with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 4
|
1.2 score on a scale
Standard Deviation 2
|
2.4 score on a scale
Standard Deviation 1.9
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 7
|
0.8 score on a scale
Standard Deviation 1.3
|
2 score on a scale
Standard Deviation 1.9
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 1
|
1.5 score on a scale
Standard Deviation 1.8
|
3.2 score on a scale
Standard Deviation 2.1
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 2
|
1.5 score on a scale
Standard Deviation 2.0
|
3.3 score on a scale
Standard Deviation 1.9
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 3
|
1.2 score on a scale
Standard Deviation 2.1
|
2.8 score on a scale
Standard Deviation 1.9
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 14
|
0.9 score on a scale
Standard Deviation 1.9
|
1.6 score on a scale
Standard Deviation 1.5
|
|
Average Pain Measured on the 11 Point Numeric Rating Scale
Postoperative day 21
|
.7 score on a scale
Standard Deviation 1.5
|
1.6 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, and 21Difficulty sleeping due to pain (binary answer: yes or no; not based on a scale or instrument). The numbers presented in the results are the number of participants in each treatment group answering YES, they DID have difficulty sleeping due to pain
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Difficultly Sleeping Due to Pain
Postoperative day 14
|
4 Participants
|
7 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 21
|
4 Participants
|
7 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 1
|
5 Participants
|
11 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 2
|
6 Participants
|
11 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 3
|
6 Participants
|
13 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 4
|
3 Participants
|
10 Participants
|
|
Difficultly Sleeping Due to Pain
Postoperative day 7
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, and 21Number of awakenings from sleep due to pain (simply the number of times of awakenings--not based on a scale or instrument)
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Number of Awakenings
Postoperative day 1
|
0.1 Awakenings
Standard Deviation 0.6
|
.8 Awakenings
Standard Deviation 1.4
|
|
Number of Awakenings
Postoperative day 2
|
.3 Awakenings
Standard Deviation 1
|
.5 Awakenings
Standard Deviation 1
|
|
Number of Awakenings
Postoperative day 3
|
.4 Awakenings
Standard Deviation 1.2
|
.9 Awakenings
Standard Deviation 1.6
|
|
Number of Awakenings
Postoperative day 14
|
.3 Awakenings
Standard Deviation 1
|
.3 Awakenings
Standard Deviation .6
|
|
Number of Awakenings
Postoperative day 21
|
.2 Awakenings
Standard Deviation .9
|
.4 Awakenings
Standard Deviation .9
|
|
Number of Awakenings
Postoperative day 4
|
.3 Awakenings
Standard Deviation .9
|
.5 Awakenings
Standard Deviation .8
|
|
Number of Awakenings
Postoperative day 7
|
.1 Awakenings
Standard Deviation .4
|
.5 Awakenings
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 14, and 21Nausea measured on a 0-10 scale with 0=no nausea and 10=vomiting; thus higher on the scale is worse
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=51 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=48 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Nausea
Postoperative day 1
|
.5 units on a scale
Standard Deviation 1.5
|
.6 units on a scale
Standard Deviation 2.1
|
|
Nausea
Postoperative day 2
|
.1 units on a scale
Standard Deviation .5
|
.3 units on a scale
Standard Deviation .9
|
|
Nausea
Postoperative day 3
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 1.1
|
|
Nausea
Postoperative day 4
|
.2 units on a scale
Standard Deviation 1.1
|
.1 units on a scale
Standard Deviation .9
|
|
Nausea
Postoperative day 7
|
.1 units on a scale
Standard Deviation .3
|
.3 units on a scale
Standard Deviation 1.7
|
|
Nausea
Postoperative day 14
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
|
Nausea
Postoperative day 21
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
How many times in the previous 3 days subject experienced phantom pain (the number of times experienced--not based on a scale or instrument)
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Phantom Pain Occurences [Mastectomy & Amputation]
Month 12
|
0 Occurrences
Standard Deviation 0
|
0.4 Occurrences
Standard Deviation 1.2
|
|
Phantom Pain Occurences [Mastectomy & Amputation]
Month 1
|
0 Occurrences
Standard Deviation 0
|
0.5 Occurrences
Standard Deviation 1.8
|
|
Phantom Pain Occurences [Mastectomy & Amputation]
Month 3
|
0 Occurrences
Standard Deviation 0
|
9.8 Occurrences
Standard Deviation 2.5
|
|
Phantom Pain Occurences [Mastectomy & Amputation]
Month 6
|
0 Occurrences
Standard Deviation 0
|
4.0 Occurrences
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
The average duration of phantom pain occurrences in the previous 3 days
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Phantom Pain Duration [Mastectomy & Amputation]
Month 1
|
0 hours
Standard Deviation 0
|
0.1 hours
Standard Deviation 0.2
|
|
Phantom Pain Duration [Mastectomy & Amputation]
Month 3
|
0 hours
Standard Deviation 0
|
0 hours
Standard Deviation 0.2
|
|
Phantom Pain Duration [Mastectomy & Amputation]
Month 6
|
0 hours
Standard Deviation 0
|
5.1 hours
Standard Deviation 20.1
|
|
Phantom Pain Duration [Mastectomy & Amputation]
Month 12
|
0 hours
Standard Deviation 0
|
0 hours
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
How many times in the previous 3 days subject experienced phantom sensations (the number of times experienced--not based on a scale or instrument). This outcome differs from "phantom pain occurrences" in that for this outcome no pain is necessary; rather, participants feel the missing body part is actually there, when it is not--yet it is not a painful sensation.
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Phantom Sensation Occurrences [Mastectomy & Amputation]
Month 1
|
0 incidences
Standard Deviation 0
|
0 incidences
Standard Deviation 0
|
|
Phantom Sensation Occurrences [Mastectomy & Amputation]
Month 3
|
0 incidences
Standard Deviation 0
|
1.2 incidences
Standard Deviation 3.1
|
|
Phantom Sensation Occurrences [Mastectomy & Amputation]
Month 6
|
0 incidences
Standard Deviation 0
|
0.5 incidences
Standard Deviation 1.7
|
|
Phantom Sensation Occurrences [Mastectomy & Amputation]
Month 12
|
0 incidences
Standard Deviation 0
|
10.3 incidences
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
The average duration of phantom sensation occurrences in the previous 3 days. This outcome differs from "phantom pain duration" in that for this outcome no pain is necessary; rather, participants feel the missing body part is actually there, when it is not--yet it is not a painful sensation.
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Phantom Sensation Duration [Mastectomy & Amputation]
Month 1
|
0 hours
Standard Deviation 0
|
0 hours
Standard Deviation 0
|
|
Phantom Sensation Duration [Mastectomy & Amputation]
Month 3
|
0 hours
Standard Deviation 0
|
0.1 hours
Standard Deviation 0.3
|
|
Phantom Sensation Duration [Mastectomy & Amputation]
Month 6
|
0 hours
Standard Deviation 0
|
1.7 hours
Standard Deviation 8.9
|
|
Phantom Sensation Duration [Mastectomy & Amputation]
Month 12
|
0 hours
Standard Deviation 0
|
7.8 hours
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
How many times in the previous 3 days subject experienced residual limb or wound pain (the number of times experienced--not based on a scale or instrument)
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Residual Limb or Wound Pain Occurences
Month 1
|
0.9 Occurrences
Standard Deviation 1.6
|
20 Occurrences
Standard Deviation 37.1
|
|
Residual Limb or Wound Pain Occurences
Month 3
|
0 Occurrences
Standard Deviation 0
|
4.4 Occurrences
Standard Deviation 18.4
|
|
Residual Limb or Wound Pain Occurences
Month 6
|
0.1 Occurrences
Standard Deviation 0.4
|
5.3 Occurrences
Standard Deviation 18.4
|
|
Residual Limb or Wound Pain Occurences
Month 12
|
0.1 Occurrences
Standard Deviation 0.4
|
1.1 Occurrences
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Postoperative months 1, 3, 6, and 12Population: mastectomy and amputee participants only (other participants did not have outcome measures collected for these time points)
The average duration of residual limb or wound pain occurrences in the previous 3 days
Outcome measures
| Measure |
ACTIVE Cryoneurolysis
n=37 Participants
Receiving active cryoneurolysis
Cryoneurolysis (active): Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle.
Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
|
SHAM Cryoneurolysis
n=32 Participants
Receiving sham cryoneurolysis procedure
Sham cryoneurolysis procedure: Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature
|
|---|---|---|
|
Residual Limb or Wound Pain Duration
Month 12
|
0 hours
Standard Deviation 0
|
0 hours
Standard Deviation 0.2
|
|
Residual Limb or Wound Pain Duration
Month 1
|
0.1 hours
Standard Deviation 0.3
|
17.6 hours
Standard Deviation 37.8
|
|
Residual Limb or Wound Pain Duration
Month 3
|
0 hours
Standard Deviation 0
|
3.5 hours
Standard Deviation 18.4
|
|
Residual Limb or Wound Pain Duration
Month 6
|
0 hours
Standard Deviation 0.2
|
5.3 hours
Standard Deviation 20.1
|
Adverse Events
ACTIVE Cryoneurolysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SHAM Cryoneurolysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place