Chemotherapy-induced Peripheral NeuropathyNCT05095051
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy
A study testing Paxman Cryocompression System (PCCS) in people with Chemotherapy-induced Peripheral Neuropathy, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Paxman Cryocompression System (PCCS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Nov 2021to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy subjects:
- Age 21-80 years
- Signed informed consent from patient or legal representative
- No history of neuropathy
- ECOG 0
- No history of hospitalization in the past 6 months
Show all 11Show fewer
- For cancer patients:
- Age 21- 80 years
- Signed informed consent from patient or legal representative
- Scheduled to receive weekly paclitaxel chemotherapy
- Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.
Who cannot join
- For healthy subjects:
- Open skin wound or ulcers of the limbs
- History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
- Pregnant women
- For cancer patients:
- Open skin wound or ulcers of the limbs
- History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.
Read the detailed description
The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.
- Being tested
- Paxman Cryocompression System (PCCS)
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Cryocompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Cryocompression System (PCCS)Device
Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression.
The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes.
Paxman Cryocompression System (PCCS)Device
The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles.
Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | To assess safety and tolerability of limb cryocompression, as well as to determine the optimal temperature and pressure to be used. The occurrence or lack of core hypothermia will be studied. Receives: Device: Paxman Cryocompression System (PCCS) |
| Cancer patients | Experimental | Once the optimal temperature and pressure of limb cryocompression is established in healthy subjects, a group of cancer patients will undergo limb cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Receives: Device: Paxman Cryocompression System (PCCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
Defined as the number of subjects with treatment-related adverse events as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Measured: During limb cryocompression procedure, 3 hours for healthy subject
Difference in tolerance scores in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain
Defined as the number of subjects with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.
Measured: During limb cryocompression procedure, 3 hours for healthy subject
Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Measured: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment
Difference in tolerance scores in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain
Defined as the number of patients with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.
Measured: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment
Secondary outcomes (2)
Difference in tolerance scores between various temperature and pressure using Common Terminology Criteria for Adverse Events 4.0 and Visual Analogue Scale for pain
Difference in tolerance scores between various temperature and pressure as assessed by CTCAE v4.0 and tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.
Measured: During limb cryocompression procedure, 3 hours for healthy subject
Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
Difference in qualitative symptom scores using the EORTC QLQ-CIPN-20 scale before, at the end of paclitaxel chemotherapy with limb cryocompression, and at 3,6 and 12 months post-treatment.
Measured: Before start of weekly paclitaxel chemotherapy, at the end of 12 cycles of weekly paclitaxel treatment, at 3-, 6-, and 12-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start3 Nov 2021
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Healthy subjects will undergo cryocompression of the various temperature and pressure levels in the cryocompression device. One temperature will be tested on 3 subjects for 3 hours. Tolerability of the temperature will be determined through a visual analogue pain scale (VAS). Should 1 out of 3 subjects display intolerance to the temperature level, 3 more healthy subjects will be tested to ensure consistency. Cancer patient limb cryocompression sessions will comprise of a pre-cooling period, continued with paclitaxel infusion and a post-cooling period. Overall, hypothermia will be administered for no longer than four hours. Each patient will undergo maximum limb cooling. The initial device settings for the first cycle for each patient will be based on the optimal temperature determined to be safe and tolerable in healthy subjects. Safety and tolerance of the concomitant cryocompression will be measured using VAS.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Paxman Coolers Ltd., National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Joline Lim, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095051
- Sponsor's protocol ID
- 2021/00288
- Status last verified
- Nov 2021
- First submitted
- 19 Sep 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Lavoie Smith EM, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. J Clin Oncol. 2020 Oct 1;38(28):3325-3348. doi: 10.1200/JCO.20.01399. Epub 2020 Jul 14.
PubMed 32663120Windebank AJ, Grisold W. Chemotherapy-induced neuropathy. J Peripher Nerv Syst. 2008 Mar;13(1):27-46. doi: 10.1111/j.1529-8027.2008.00156.x.
PubMed 18346229Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.
PubMed 28119855Jordan B, Margulies A, Cardoso F, Cavaletti G, Haugnes HS, Jahn P, Le Rhun E, Preusser M, Scotte F, Taphoorn MJB, Jordan K; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org; EONS Education Working Group. Electronic address: eons.secretariat@cancernurse.eu; EANO Guideline Committee. Electronic address: office@eano.eu. Systemic anticancer therapy-induced peripheral and central neurotoxicity: ESMO-EONS-EANO Clinical Practice Guidelines for diagnosis, prevention, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1306-1319. doi: 10.1016/j.annonc.2020.07.003. Epub 2020 Jul 30. No abstract available.
PubMed 32739407Bandla A, Tan S, Kumarakulasinghe NB, Huang Y, Ang S, Magarajah G, Hairom Z, Lim JSJ, Wong A, Chan G, Ngoi N, Ang E, Lee YM, Chan A, Lee SC, Thakor N, Wilder-Smith E, Sundar R. Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Support Care Cancer. 2020 Aug;28(8):3691-3699. doi: 10.1007/s00520-019-05177-2. Epub 2019 Dec 6.
PubMed 31811482
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05095051
- Acronym / sponsor ID
- 2021/00288
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Cryocompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Paxman Coolers Ltd., National University of Singapore
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.
Detailed description
The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy subjects will undergo cryocompression of the various temperature and pressure levels in the cryocompression device. One temperature will be tested on 3 subjects for 3 hours. Tolerability of the temperature will be determined through a visual analogue pain scale (VAS). Should 1 out of 3 subjects display intolerance to the temperature level, 3 more healthy subjects will be tested to ensure consistency. Cancer patient limb cryocompression sessions will comprise of a pre-cooling period, continued with paclitaxel infusion and a post-cooling period. Overall, hypothermia will be administered for no longer than four hours. Each patient will undergo maximum limb cooling. The initial device settings for the first cycle for each patient will be based on the optimal temperature determined to be safe and tolerable in healthy subjects. Safety and tolerance of the concomitant cryocompression will be measured using VAS.
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: Paxman Cryocompression System (PCCS)To assess safety and tolerability of limb cryocompression, as well as to determine the optimal temperature and pressure to be used. The occurrence or lack of core hypothermia will be studied. |
| Cancer patients | Experimental | Device: Paxman Cryocompression System (PCCS)Once the optimal temperature and pressure of limb cryocompression is established in healthy subjects, a group of cancer patients will undergo limb cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For healthy subjects:
- For cancer patients:
Key exclusion criteria (8 listed)
- For healthy subjects:
- For cancer patients:
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 |
|---|---|---|
| Paxman Cryocompression System (PCCS)Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression. The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes. | Device | Healthy subjects |
| Paxman Cryocompression System (PCCS)The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles. Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours. | Device | Cancer patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
Time frame: During limb cryocompression procedure, 3 hours for healthy subject
Defined as the number of subjects with treatment-related adverse events as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Difference in tolerance scores in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain
Time frame: During limb cryocompression procedure, 3 hours for healthy subject
Defined as the number of subjects with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.
Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
Time frame: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment
Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Difference in tolerance scores in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain
Time frame: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment
Defined as the number of patients with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.
2 secondary outcomes
Difference in tolerance scores between various temperature and pressure using Common Terminology Criteria for Adverse Events 4.0 and Visual Analogue Scale for pain
Time frame: During limb cryocompression procedure, 3 hours for healthy subject
Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
Time frame: Before start of weekly paclitaxel chemotherapy, at the end of 12 cycles of weekly paclitaxel treatment, at 3-, 6-, and 12-months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 32663120Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Lavoie Smith EM, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. J Clin Oncol. 2020 Oct 1;38(28):3325-3348. doi: 10.1200/JCO.20.01399. Epub 2020 Jul 14.
- Background: PubMed 18346229Windebank AJ, Grisold W. Chemotherapy-induced neuropathy. J Peripher Nerv Syst. 2008 Mar;13(1):27-46. doi: 10.1111/j.1529-8027.2008.00156.x.
- Background: PubMed 28119855Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.
- Background: PubMed 32739407Jordan B, Margulies A, Cardoso F, Cavaletti G, Haugnes HS, Jahn P, Le Rhun E, Preusser M, Scotte F, Taphoorn MJB, Jordan K; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org; EONS Education Working Group. Electronic address: eons.secretariat@cancernurse.eu; EANO Guideline Committee. Electronic address: office@eano.eu. Systemic anticancer therapy-induced peripheral and central neurotoxicity: ESMO-EONS-EANO Clinical Practice Guidelines for diagnosis, prevention, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1306-1319. doi: 10.1016/j.annonc.2020.07.003. Epub 2020 Jul 30. No abstract available.
- Background: PubMed 31811482Bandla A, Tan S, Kumarakulasinghe NB, Huang Y, Ang S, Magarajah G, Hairom Z, Lim JSJ, Wong A, Chan G, Ngoi N, Ang E, Lee YM, Chan A, Lee SC, Thakor N, Wilder-Smith E, Sundar R. Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Support Care Cancer. 2020 Aug;28(8):3691-3699. doi: 10.1007/s00520-019-05177-2. Epub 2019 Dec 6.
- 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.
Joline Lim principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paxman Cryocompression System (PCCS) in people with Chemotherapy-induced Peripheral Neuropathy, run by National University Hospital, Singapore at 1 site in Singapore.
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 11 inclusion and 8 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0 (time frame: During limb cryocompression procedure, 3 hours for healthy subject). The study lists 4 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 NCT05095051, which also lists 5 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 22 Jun 2026.