Trial Outcomes & Findings for The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST) (NCT NCT02922153)

Last Updated: 2020-09-04

Results Overview

Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

48-hours post-surgery

Results posted on

2020-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cryoanalgesia + Standard of Care (SOC) Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Overall Study STARTED	65	19
Overall Study COMPLETED	55	17
Overall Study NOT COMPLETED	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cryoanalgesia + Standard of Care (SOC) Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Overall Study Death	8	1
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	1

Baseline Characteristics

The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoanalgesia + Standard of Care (SOC) n=65 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.	Total n=84 Participants Total of all reporting groups
Age, Continuous	63.83 years STANDARD_DEVIATION 11.96 • n=65 Participants	66.42 years STANDARD_DEVIATION 12.53 • n=19 Participants	64.42 years STANDARD_DEVIATION 12.06 • n=84 Participants
Sex: Female, Male Female	27 Participants n=65 Participants	8 Participants n=19 Participants	35 Participants n=84 Participants
Sex: Female, Male Male	38 Participants n=65 Participants	11 Participants n=19 Participants	49 Participants n=84 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=65 Participants	1 Participants n=19 Participants	1 Participants n=84 Participants
Race (NIH/OMB) Asian	0 Participants n=65 Participants	0 Participants n=19 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=65 Participants	0 Participants n=19 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Black or African American	1 Participants n=65 Participants	0 Participants n=19 Participants	1 Participants n=84 Participants
Race (NIH/OMB) White	59 Participants n=65 Participants	18 Participants n=19 Participants	77 Participants n=84 Participants
Race (NIH/OMB) More than one race	0 Participants n=65 Participants	0 Participants n=19 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=65 Participants	0 Participants n=19 Participants	5 Participants n=84 Participants
Region of Enrollment United States	65 participants n=65 Participants	19 participants n=19 Participants	84 participants n=84 Participants
Body Mass Index (BMI)	28.61 kg/m^2 STANDARD_DEVIATION 5.03 • n=65 Participants	29.95 kg/m^2 STANDARD_DEVIATION 4.73 • n=19 Participants	28.91 kg/m^2 STANDARD_DEVIATION 4.96 • n=84 Participants
Forced Expiratory Value (FEV1)	2.33 Liters (L) STANDARD_DEVIATION 0.78 • n=65 Participants	2.28 Liters (L) STANDARD_DEVIATION 0.84 • n=19 Participants	2.32 Liters (L) STANDARD_DEVIATION 0.79 • n=84 Participants
Visual Analog Scale (general)	0.32 units on a scale STANDARD_DEVIATION 0.95 • n=65 Participants	0.42 units on a scale STANDARD_DEVIATION 0.90 • n=19 Participants	0.35 units on a scale STANDARD_DEVIATION 0.94 • n=84 Participants
Visual Analog Scale (surgical site)	0.03 units on a scale STANDARD_DEVIATION 0.25 • n=65 Participants	0.21 units on a scale STANDARD_DEVIATION 0.54 • n=19 Participants	0.07 units on a scale STANDARD_DEVIATION 0.34 • n=84 Participants
Society of Thoracic Surgeon Score (STS)	2.03 Percentage STANDARD_DEVIATION 1.90 • n=60 Participants • The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants.	2.86 Percentage STANDARD_DEVIATION 2.57 • n=19 Participants • The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants.	2.23 Percentage STANDARD_DEVIATION 2.09 • n=79 Participants • The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants.

PRIMARY outcome

Timeframe: 48-hours post-surgery

Population: Includes all patients who were consented and randomized (84). Not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for Cryoanalgesia (CRYO) + SOC and 16/19 subjects for SOC.

Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=46 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=16 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery	1.2 Liters (L) Interval 1.1 to 1.31	0.93 Liters (L) Interval 0.71 to 1.14

PRIMARY outcome

Timeframe: 48-hours post-surgery

Population: Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 61/64 subject for CRYO + SOC and 18/19 subjects for SOC.

The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=61 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=18 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery	2.82 units on a scale Standard Deviation 2.70	3.06 units on a scale Standard Deviation 2.82

SECONDARY outcome

Timeframe: 48-hours post-extubation

Population: Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for CRYO + SOC and 16/19 subjects for SOC.

Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=46 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=16 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation FVC	1.60 Liters (L) Standard Deviation 0.62	1.33 Liters (L) Standard Deviation 0.55
Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation SVC	1.52 Liters (L) Standard Deviation 0.61	1.28 Liters (L) Standard Deviation 0.55
Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation FEV1	1.20 Liters (L) Standard Deviation 0.46	0.93 Liters (L) Standard Deviation 0.43

SECONDARY outcome

Timeframe: 72-, 96- and 120-hours Post-Op

Population: Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=64 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points 72 Hours Post-Op	2.08 units on a scale Standard Deviation 2.39	1.44 units on a scale Standard Deviation 2.09
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points 96 Hours Post-Op	1.84 units on a scale Standard Deviation 2.39	2.00 units on a scale Standard Deviation 2.45
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points 120 Hours Post-Op	2.50 units on a scale Standard Deviation 2.82	2.40 units on a scale Standard Deviation 3.37

SECONDARY outcome

Timeframe: 3 and 6 Months

Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=64 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit 3 Month	0 Participants	0 Participants
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit 6 Month	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Hours until patient is extubated from time patient leaves the operating room

Population: Overall number is for all patients that were fully extubated and accounts for patients who were unable to be extubated or did were unable to finish extubation.

Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=60 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room	8.85 Hours Standard Deviation 11.16	7.33 Hours Standard Deviation 4.51

SECONDARY outcome

Timeframe: 24-, 48, -96 and 120-hours

Population: Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.

Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=63 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points 48 Hours	20.91 Morphine Milligram Equivalent (MME) Standard Deviation 23.45	31.05 Morphine Milligram Equivalent (MME) Standard Deviation 36.02
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points 96 Hours	14.87 Morphine Milligram Equivalent (MME) Standard Deviation 19.82	16.67 Morphine Milligram Equivalent (MME) Standard Deviation 44.52
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points 120 Hours	14.10 Morphine Milligram Equivalent (MME) Standard Deviation 18.58	13.13 Morphine Milligram Equivalent (MME) Standard Deviation 20.40
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points Total Post-Procedure for Hospital Stay	33.43 Morphine Milligram Equivalent (MME) Standard Deviation 29.77	38.31 Morphine Milligram Equivalent (MME) Standard Deviation 31.05
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points 24 Hours	11.43 Morphine Milligram Equivalent (MME) Standard Deviation 14.54	17.32 Morphine Milligram Equivalent (MME) Standard Deviation 23.65

SECONDARY outcome

Timeframe: Procedure to Discharge

The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=60 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge Hospital Length of Stay	9.40 Days Standard Deviation 8.34	6.32 Days Standard Deviation 2.56
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge ICU Length of Stay	4.96 Days Standard Deviation 7.75	2.96 Days Standard Deviation 2.24

SECONDARY outcome

Timeframe: Baseline, 48, 72, 96, 120 Hours and Discharge

Population: Initial patient population was 65 and 19 for the CRYO arm and SOC arm respectively. Number of patients analysed at the time points below differs due to the following: patient unwilling or refused test, patient discharged from hospital or other patient hospital stay issues.

Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.

Outcome measures

Outcome measures
Measure	Cryoanalgesia + SOC n=65 Participants Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 Participants Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to sit up in bed · Yes - Independently	65 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to sit up in bed · Yes - with assistance	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to walk · Yes - Independently	64 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to walk · Yes - with assistance	1 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to walk · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Right shoulder flexion movement · Yes - with assistance	17 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Right shoulder flexion movement · No	1 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Left shoulder flexion movement · Yes - with assistance	8 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Left shoulder flexion movement · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to sit up in bed · Yes - Independently	41 Participants	12 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to sit up in bed · Yes - with assistance	10 Participants	3 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to stand up · Yes - with assistance	19 Participants	6 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to stand up · No	0 Participants	1 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to walk · No	4 Participants	1 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Left shoulder flexion movement · Yes - with assistance	6 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Left shoulder flexion movement · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to sit up in bed · Yes - Independently	36 Participants	7 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to sit up in bed · Yes - Independently	53 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Left shoulder flexion movement · No	4 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to walk · No	4 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Right shoulder flexion movement · Yes - Independently	41 Participants	12 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Left shoulder flexion movement · Yes - Independently	49 Participants	15 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to stand up · Yes - Independently	32 Participants	8 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to walk · Yes - Independently	26 Participants	7 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Able to walk · Yes - with assistance	21 Participants	7 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Right shoulder flexion movement · Yes - Independently	39 Participants	11 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Right shoulder flexion movement · Yes - with assistance	11 Participants	4 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Right shoulder flexion movement · No	1 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 96 Hours - Left shoulder flexion movement · Yes - Independently	43 Participants	13 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to sit up in bed · Yes - with assistance	6 Participants	3 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to stand up · Yes - Independently	30 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to stand up · Yes - with assistance	12 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to stand up · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to walk · Yes - Independently	23 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to walk · Yes - with assistance	17 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Able to walk · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Right shoulder flexion movement · Yes - Independently	34 Participants	9 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Right shoulder flexion movement · Yes - with assistance	8 Participants	1 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Right shoulder flexion movement · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Left shoulder flexion movement · Yes - Independently	37 Participants	10 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Left shoulder flexion movement · Yes - with assistance	5 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 120 Hours - Left shoulder flexion movement · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to sit up in bed · Yes - with assistance	7 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to stand up · Yes - Independently	51 Participants	17 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to stand up · Yes - with assistance	7 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to stand up · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to walk · Yes - Independently	50 Participants	15 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to walk · Yes - with assistance	8 Participants	4 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Able to walk · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Right shoulder flexion movement · Yes - Independently	54 Participants	16 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Right shoulder flexion movement · Yes - with assistance	6 Participants	3 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Right shoulder flexion movement · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Left shoulder flexion movement · Yes - Independently	51 Participants	16 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Discharge - Left shoulder flexion movement · Yes - with assistance	5 Participants	3 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to stand up · Yes - Independently	64 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to stand up · Yes - with assistance	1 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Able to stand up · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Right shoulder flexion movement · Yes - Independently	63 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Right shoulder flexion movement · Yes - with assistance	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Right shoulder flexion movement · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Left shoulder flexion movement · Yes - Independently	64 Participants	19 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Left shoulder flexion movement · Yes - with assistance	1 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay Baseline - Left shoulder flexion movement · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to sit up in bed · Yes - Independently	34 Participants	7 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to sit up in bed · Yes - with assistance	27 Participants	10 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to stand up · Yes - Independently	21 Participants	4 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to stand up · Yes - with assistance	38 Participants	12 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to stand up · No	2 Participants	1 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to walk · Yes - Independently	16 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to walk · Yes - with assistance	38 Participants	13 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Able to walk · No	7 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Right shoulder flexion movement · Yes - Independently	26 Participants	8 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Right shoulder flexion movement · Yes - with assistance	33 Participants	8 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Right shoulder flexion movement · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Left shoulder flexion movement · Yes - Independently	43 Participants	12 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Left shoulder flexion movement · Yes - with assistance	16 Participants	4 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 48 Hours - Left shoulder flexion movement · No	2 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to sit up in bed · Yes - Independently	47 Participants	8 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to sit up in bed · Yes - with assistance	12 Participants	9 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to sit up in bed · No	0 Participants	0 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to stand up · Yes - Independently	39 Participants	5 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to stand up · Yes - with assistance	20 Participants	10 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to stand up · No	0 Participants	2 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to walk · Yes - Independently	28 Participants	4 Participants
Secondary Outcome 7: Ambulatory Movement During Hospital Stay 72 Hours - Able to walk · Yes - with assistance	27 Participants	11 Participants

Adverse Events

Cryoanalgesia + SOC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 8 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cryoanalgesia + SOC n=65 participants at risk Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Cryoanalgesia: AtriCure® cryoICE cryo-ablation system Standard of Care: Institutional SOC for pain management will be followed.	Standard of Care n=19 participants at risk Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. Standard of Care: Institutional SOC for pain management will be followed.
Musculoskeletal and connective tissue disorders Right Breast Pain/Numbness	1.5% 1/65 • Number of events 1 • Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit. The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.	0.00% 0/19 • Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit. The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.
Musculoskeletal and connective tissue disorders Hyperesthesia	1.5% 1/65 • Number of events 1 • Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit. The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.	0.00% 0/19 • Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit. The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.

Additional Information

Nfii Ndikitum

AtriCure

Phone: 513-644-8192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place