PainFROSTNCT02922153

The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

A study testing Cryoanalgesia in people with Pain, run by AtriCure, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Pain
What is being tested?: Cryoanalgesia
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 5 sitesUnited States
Study dates: 13 Jun 2016to 28 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 - 85 years male or female
Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
Acceptable surgical candidate, including use of general anesthesia
Willing and able to provide written informed consent
Willing and able to return for scheduled follow-up visits

Who cannot join

Cardiac valve surgical procedure via conventional full sternotomy
Procedures that require a posterolateral thoracotomy
Current pregnancy
Current use of prescription opioids
FEV1 < 40% predicted
Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)

Show all 12Show fewer

Documented psychiatric disease
Documented chronic pain syndrome
Documented history of substance abuse
Patient currently enrolled in another research study that could directly affect results of either study
Physical or mental condition that would interfere with patient's self-assessment of pain
Disqualifying medical condition per investigator

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 44195
University of Southern California (USC)
Los Angeles, California, 90033
William Beaumont Hospital
Royal Oak, Michigan, 48073
United Heart and Vascular Institute - Allina
Saint Paul, Minnesota, 55102

Other trials in United States

About this study

Read the detailed description

Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Conditions: Pain
Being tested: Cryoanalgesia, Standard of Care
Keywords: CryoAnalgesia, Thoracotomy, Forced Expiratory Volume (FEV1), Visual Analog Scale (VAS)
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CryoanalgesiaDevice
Also called cryoICE
AtriCure® cryoICE cryo-ablation system
Standard of CareDrug
Also called SOC
Institutional SOC for pain management will be followed.

Study groups in NCT02922153
Study group	Role	What they receive
Cryoanalgesia + Standard of Care (SOC)	Experimental	Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. Receives: Device: Cryoanalgesia; Drug: Standard of Care
Standard of Care	Active comparator	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. Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
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.
Measured: 48-hours post-surgery
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
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.
Measured: 48-hours post-surgery

Secondary outcomes (7)

Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation
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.
Measured: 48-hours post-extubation
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points
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.
Measured: 72-, 96- and 120-hours Post-Op
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit
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.
Measured: 3 and 6 Months
Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room
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.
Measured: Hours until patient is extubated from time patient leaves the operating room
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points
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.
Measured: 24-, 48, -96 and 120-hours
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge
The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.
Measured: Procedure to Discharge
Secondary Outcome 7: Ambulatory Movement During Hospital Stay
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.
Measured: Baseline, 48, 72, 96, 120 Hours and Discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201628 Aug 2019

First posted4 Oct 2016 (estimated)
Study start13 Jun 2016
Primary completion4 Mar 2019
Study completion28 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02922153
Sponsor's protocol ID: CP2015-4
Acronym: FROST
Status last verified: Apr 2020
First submitted: 26 Sep 2016
Last updated: 4 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
PubMed 23424242
Moorjani N, Zhao F, Tian Y, Liang C, Kaluba J, Maiwand MO. Effects of cryoanalgesia on post-thoracotomy pain and on the structure of intercostal nerves: a human prospective randomized trial and a histological study. Eur J Cardiothorac Surg. 2001 Sep;20(3):502-7. doi: 10.1016/s1010-7940(01)00815-6.
PubMed 11509270
Glauber M, Karimov JH, Farneti PA, Cerillo AG, Santarelli F, Ferrarini M, Del Sarto P, Murzi M, Solinas M. Minimally invasive mitral valve surgery via right minithoracotomy. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(122):mmcts.2008.003350. doi: 10.1510/mmcts.2008.003350.
PubMed 24415737
Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available.
PubMed 4859864
PAPPER EM, BRODIE BB, ROVENSTINE EA. Postoperative pain; its use in the comparative evaluation of analgesics. Surgery. 1952 Jul;32(1):107-9. No abstract available.
PubMed 14950594
Katz J. Cryoanalgesia for postthoracotomy pain. Ann Thorac Surg. 1989 Jul;48(1):5. doi: 10.1016/0003-4975(89)90166-5. No abstract available.
PubMed 2764599
Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.
PubMed 9352765
SIMPSON BR, PARKHOUSE J, MARSHALL R, LAMBRECHTS W. Extradural analgesia and the prevention of postoperative respiratory complications. Br J Anaesth. 1961 Dec;33:628-41. doi: 10.1093/bja/33.12.628. No abstract available.
PubMed 13913200
Maiwand MO, Makey AR, Rees A. Cryoanalgesia after thoracotomy. Improvement of technique and review of 600 cases. J Thorac Cardiovasc Surg. 1986 Aug;92(2):291-5.
PubMed 3736085
Gough JD, Williams AB, Vaughan RS, Khalil JF, Butchart EG. The control of post-thoracotomy pain. A comparative evaluation of thoracic epidural fentanyl infusions and cryo-analgesia. Anaesthesia. 1988 Sep;43(9):780-3. doi: 10.1111/j.1365-2044.1988.tb05757.x.
PubMed 3255292
Gwak MS, Yang M, Hahm TS, Cho HS, Cho CH, Song JG. Effect of cryoanalgesia combined with intravenous continuous analgesia in thoracotomy patients. J Korean Med Sci. 2004 Feb;19(1):74-8. doi: 10.3346/jkms.2004.19.1.74.
PubMed 14966345
Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
PubMed 34545530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
ClinicalTrials.gov ID: NCT02922153
Acronym / sponsor ID: FROST / CP2015-4
Conditions: Pain
Keywords: CryoAnalgesia, Thoracotomy, Forced Expiratory Volume (FEV1), Visual Analog Scale (VAS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: AtriCure, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jun 2016 (actual)
Primary completion: 4 Mar 2019 (actual)
Study completion: 28 Aug 2019 (actual)
First posted: 4 Oct 2016 (estimated)
Results: Posted 4 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cryoanalgesia + Standard of Care (SOC)	Experimental	Device: Cryoanalgesia, Drug: Standard of CareCryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Standard of Care	Active comparator	Drug: Standard of CareInstitutional 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18 - 85 years male or female
Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
Acceptable surgical candidate, including use of general anesthesia
Willing and able to provide written informed consent
Willing and able to return for scheduled follow-up visits

Key exclusion criteria (12 listed)

Cardiac valve surgical procedure via conventional full sternotomy
Procedures that require a posterolateral thoracotomy
Current pregnancy
Current use of prescription opioids
FEV1 < 40% predicted

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CryoanalgesiaAlso: cryoICEAtriCure® cryoICE cryo-ablation system	Device	Cryoanalgesia + Standard of Care (SOC)
Standard of CareAlso: SOCInstitutional SOC for pain management will be followed.	Drug	Cryoanalgesia + Standard of Care (SOC), Standard of Care

Primary outcome

Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
Time frame: 48-hours post-surgery
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.
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
Time frame: 48-hours post-surgery
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.

7 secondary outcomes

Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation
Time frame: 48-hours post-extubation
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points
Time frame: 72-, 96- and 120-hours Post-Op
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit
Time frame: 3 and 6 Months
Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room
Time frame: Hours until patient is extubated from time patient leaves the operating room
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points
Time frame: 24-, 48, -96 and 120-hours
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge
Time frame: Procedure to Discharge
Secondary Outcome 7: Ambulatory Movement During Hospital Stay
Time frame: Baseline, 48, 72, 96, 120 Hours and Discharge

Results and safety

Results posted to the registry on 4 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryoanalgesia + Standard of Care (SOC)	65	55
Standard of Care	19	17

Primary outcome: Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery

Time frame: 48-hours post-surgery. Least squares mean (95% Confidence Interval). Unit: Liters (L)

Measure	Cryoanalgesia + SOC n = 46	Standard of Care n = 16
Value	1.2 (1.10 to 1.31)	0.93 (.71 to 1.14)

Cryoanalgesia + SOC vs Standard of Care: p = 0.0223, t-test, 1 sided

Population analysed: 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.

Primary outcome: Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery

Time frame: 48-hours post-surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Cryoanalgesia + SOC n = 61	Standard of Care n = 18
Value	2.82 (2.70)	3.06 (2.82)

Cryoanalgesia + SOC vs Standard of Care: p = 0.6259, t-test, 1 sided
Cryoanalgesia + SOC vs Standard of Care: p = 0.518, Wilcoxon (Mann-Whitney)

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryoanalgesia + SOC	0 of 65 (0%)	2 of 65 (3.1%)	8 of 65
Standard of Care	0 of 19 (0%)	0 of 19 (0%)	1 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23424242Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
Background: PubMed 11509270Moorjani N, Zhao F, Tian Y, Liang C, Kaluba J, Maiwand MO. Effects of cryoanalgesia on post-thoracotomy pain and on the structure of intercostal nerves: a human prospective randomized trial and a histological study. Eur J Cardiothorac Surg. 2001 Sep;20(3):502-7. doi: 10.1016/s1010-7940(01)00815-6.
Background: PubMed 24415737Glauber M, Karimov JH, Farneti PA, Cerillo AG, Santarelli F, Ferrarini M, Del Sarto P, Murzi M, Solinas M. Minimally invasive mitral valve surgery via right minithoracotomy. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(122):mmcts.2008.003350. doi: 10.1510/mmcts.2008.003350.
Background: PubMed 4859864Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available.
Background: PubMed 14950594PAPPER EM, BRODIE BB, ROVENSTINE EA. Postoperative pain; its use in the comparative evaluation of analgesics. Surgery. 1952 Jul;32(1):107-9. No abstract available.
Background: PubMed 2764599Katz J. Cryoanalgesia for postthoracotomy pain. Ann Thorac Surg. 1989 Jul;48(1):5. doi: 10.1016/0003-4975(89)90166-5. No abstract available.
Background: PubMed 9352765Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.
Background: PubMed 13913200SIMPSON BR, PARKHOUSE J, MARSHALL R, LAMBRECHTS W. Extradural analgesia and the prevention of postoperative respiratory complications. Br J Anaesth. 1961 Dec;33:628-41. doi: 10.1093/bja/33.12.628. No abstract available.
Background: PubMed 3736085Maiwand MO, Makey AR, Rees A. Cryoanalgesia after thoracotomy. Improvement of technique and review of 600 cases. J Thorac Cardiovasc Surg. 1986 Aug;92(2):291-5.
Background: PubMed 3255292Gough JD, Williams AB, Vaughan RS, Khalil JF, Butchart EG. The control of post-thoracotomy pain. A comparative evaluation of thoracic epidural fentanyl infusions and cryo-analgesia. Anaesthesia. 1988 Sep;43(9):780-3. doi: 10.1111/j.1365-2044.1988.tb05757.x.
Background: PubMed 14966345Gwak MS, Yang M, Hahm TS, Cho HS, Cho CH, Song JG. Effect of cryoanalgesia combined with intravenous continuous analgesia in thoracotomy patients. J Korean Med Sci. 2004 Feb;19(1):74-8. doi: 10.3346/jkms.2004.19.1.74.
Derived from this study: PubMed 34545530Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Lau, MD principal investigator

Corewell Health East

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cryoanalgesia in people with Pain, run by AtriCure, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery (time frame: 48-hours post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922153, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.