Trial Outcomes & Findings for Intercostal Cryoneurolysis Following Traumatic Rib Fractures (NCT NCT03917823)
NCT ID: NCT03917823
Last Updated: 2021-03-11
Results Overview
Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Day following treatment
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
Cryoneurolysis (Active)
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cryoneurolysis (Active)
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=2 Participants
|
54.5 years
n=2 Participants
|
57.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Height (m)
|
1.75 meters
n=2 Participants
|
1.75 meters
n=2 Participants
|
1.75 meters
n=4 Participants
|
|
Weight (kg)
|
93.0 kg
n=2 Participants
|
97.6 kg
n=2 Participants
|
95.3 kg
n=4 Participants
|
PRIMARY outcome
Timeframe: Day following treatmentPain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Average Resting Pain Score
|
5.0 score on a scale
Standard Deviation 2.8
|
8.3 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Days 2-4, Weeks 1-3, Months 1,3,6Population: One subject from the treatment/experimental group could not be reached Months 3 and 6; one subject from the control group dropped out after postoperative day 1; and one subject from the control group could not be reached Month 6
Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Average Pain Score
Month 6
|
0 score on a scale
Standard Deviation 0
|
—
|
|
Average Pain Score
Day 2
|
1.5 score on a scale
Standard Deviation 2.1
|
8.3 score on a scale
Standard Deviation 0.4
|
|
Average Pain Score
Day 3
|
3.5 score on a scale
Standard Deviation 4.9
|
8.5 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Day 4
|
1.5 score on a scale
Standard Deviation 2.1
|
8.0 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Week 1
|
2.0 score on a scale
Standard Deviation 2.8
|
8.0 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Week 2
|
1.0 score on a scale
Standard Deviation 1.4
|
4.5 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Week 3
|
1.0 score on a scale
Standard Deviation 1.4
|
3.5 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Week 4
|
1.0 score on a scale
Standard Deviation 1.4
|
4.5 score on a scale
Standard Deviation 0
|
|
Average Pain Score
Month 3
|
1.0 score on a scale
Standard Deviation 0
|
3.0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1-4, weeks 1-4, months 3 & 6Population: One patient withdrew and 2 patients were lost to follow-up
Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain
Outcome measures
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Worst Pain Score
Day 1
|
7.5 score on a scale
Standard Deviation 3.5
|
9.8 score on a scale
Standard Deviation 0.4
|
|
Worst Pain Score
Day 2
|
4.0 score on a scale
Standard Deviation 5.7
|
9.5 score on a scale
Standard Deviation 0.7
|
|
Worst Pain Score
Day 3
|
4.3 score on a scale
Standard Deviation 6
|
10 score on a scale
|
|
Worst Pain Score
Day 4
|
3.5 score on a scale
Standard Deviation 4.9
|
10 score on a scale
|
|
Worst Pain Score
Week 1
|
3.3 score on a scale
Standard Deviation 4.6
|
10 score on a scale
|
|
Worst Pain Score
Week 2
|
3.5 score on a scale
Standard Deviation 4.9
|
7.5 score on a scale
|
|
Worst Pain Score
Week 3
|
3.0 score on a scale
Standard Deviation 4.2
|
7.0 score on a scale
|
|
Worst Pain Score
Week 4
|
3.0 score on a scale
Standard Deviation 4.2
|
5.0 score on a scale
|
|
Worst Pain Score
Month 3
|
4.5 score on a scale
|
7.0 score on a scale
|
|
Worst Pain Score
Month 6
|
0 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Days 1-4, 7, 14, 21, and months 1, 3 and 6Population: One subject withdrew and two subjects were lost to follow-up
Number of opioid tablets consumed previous 24 hours (oxycodone 5 mg)
Outcome measures
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Opioid Consumption
Day 1
|
5.5 opioid tablets (5mg oxycodone)
Standard Deviation 6.5
|
2.8 opioid tablets (5mg oxycodone)
Standard Deviation 3.9
|
|
Opioid Consumption
Day 2
|
0.5 opioid tablets (5mg oxycodone)
Standard Deviation 0.7
|
14.5 opioid tablets (5mg oxycodone)
Standard Deviation 4.9
|
|
Opioid Consumption
Day 3
|
1.0 opioid tablets (5mg oxycodone)
Standard Deviation 1.4
|
18 opioid tablets (5mg oxycodone)
Standard Deviation 10
|
|
Opioid Consumption
Day 4
|
1.0 opioid tablets (5mg oxycodone)
Standard Deviation 1.4
|
24.0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Week 1
|
2.0 opioid tablets (5mg oxycodone)
Standard Deviation 2.8
|
22.0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Week 2
|
2.0 opioid tablets (5mg oxycodone)
Standard Deviation 2.8
|
10 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Week 3
|
1.5 opioid tablets (5mg oxycodone)
Standard Deviation 2.1
|
12.0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Week 4
|
0.5 opioid tablets (5mg oxycodone)
Standard Deviation 0.7
|
0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Month 3
|
0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
|
Opioid Consumption
Month 6
|
0 opioid tablets (5mg oxycodone)
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Days 1-4, 7, 14, and 21Population: some subjects were lost to follow-up and one withdrew
maximum incentive spirometer volume
Outcome measures
| Measure |
Cryoneurolysis (Active)
n=2 Participants
The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.
Cryoneurolysis: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
|
Sham
n=2 Participants
For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
Sham comparator: For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Incentive Spirometer Volume
Day 1
|
2625 mL
Standard Deviation 530
|
1675 mL
Standard Deviation 1520
|
|
Incentive Spirometer Volume
Day 2
|
2375 mL
Standard Deviation 177
|
1575 mL
Standard Deviation 1662
|
|
Incentive Spirometer Volume
Day 3
|
2500 mL
Standard Deviation 354
|
500 mL
|
|
Incentive Spirometer Volume
Day 4
|
2875 mL
Standard Deviation 884
|
500 mL
|
|
Incentive Spirometer Volume
Day 7
|
2750 mL
Standard Deviation 707
|
750 mL
|
|
Incentive Spirometer Volume
Day 14
|
2875 mL
Standard Deviation 884
|
1250 mL
|
|
Incentive Spirometer Volume
Day 21
|
2875 mL
Standard Deviation 884
|
1250 mL
|
Adverse Events
Cryoneurolysis (Active)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Ilfeld, MD, MS
University of California San Diego
Phone: 858-822-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place