BloodNCT05329493
A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
A study testing Cooling digit device application in people with Blood, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood
- What is being tested?
- Cooling digit device application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 8 Nov 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent to participate in the study.
- Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment.
- All Fitzpatrick Skin Types are eligible
- General good health confirmed by medical history and skin examination of the area to be treated
- Subjects fifth finger is 17-23mm in diameter at the distal phalanges.
Who cannot join
- • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.
- Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia
- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
- History of keloid scarring, abnormal wound healing and /or prone to bruising.
- History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders
Show all 9Show fewer
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
- Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, 02114
About this study
In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips.
Read the detailed description
Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers.The fingerstick blood draw has been used as an alternative.
Aiming a less painful, potentially easier alternative we devised a novel that can be applied distally on the digit prior to the blood collection procedure and may provide analgesia through a liquid coolant that is run through tubes in the device to safely cool tissue to achieve numbing. We hypothesize that this device will safely and effectively reduce the pain associated with the fingertip pricks and increase the amount of capillary blood collected.
Multiple punctures with a large lancet were a frequent cause of discomfort among patients.With this new device the discomfort will be reduced by its application followed by the numbness of the finger.
The investigators plan to have 12 patients to complete the study. Subjects must be equal to greater than 18 years old and younger than 60 years older and may be any gender or Fitzpatrick skin type.
- Conditions
- Blood
- Being tested
- Cooling digit device application
- Keywords
- Blood Draw, Fingerstick Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling digit device applicationDevice
Also called cooling finger device
Cooling digit device will be applied on subject's right hand ( fifth finger).
| Study group | Role | What they receive |
|---|---|---|
| Cooling digit device application | Experimental | Device: Cooling digit device. The cooling finger device will be applied in the subjects on their right hand. Subjects will serve as their own control. Receives: Device: Cooling digit device application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
This scale will be used to record subject pain from the overall pain from the procedure for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst.
Measured: day 1
Secondary outcomes (2)
Blood Absorption Via Whatman 903 Filter Paper (Surface Area)
After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.
Measured: Day 1
Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)
After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start21 Jun 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
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 (4)Papers the sponsor has linked to this study.
- Other trials for BloodStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Manstein, MD, Massachusetts General Hospital
- Investigators
- Dieter Manstein, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329493
- Sponsor's protocol ID
- 2022P000271
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2022
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Jankowski CA, Casapao AM, Siller S, Isache C, Cani KV, Claudio AM, Brown M, Milstid B, Feldhammer M. Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients. Am J Clin Pathol. 2021 Feb 11;155(3):412-417. doi: 10.1093/ajcp/aqaa138.
PubMed 33009571Kertes DA, Kamin HS, Liu J, Bhatt SS, Kelly M. Putting a finger on the problem: Finger stick blood draw and immunization at the well-child exam elicit a cortisol response to stress among one-year-old children. Psychoneuroendocrinology. 2018 Jul;93:103-106. doi: 10.1016/j.psyneuen.2018.04.021. Epub 2018 Apr 22.
PubMed 29705575Iwasawa H, Nishimura T, Nemoto S, Aikawa N, Watanabe K. Correlation of the Blood Test Results Obtained between Assays Using Microliter-scale Fingertip Blood Samples Collected with a Novel Blood Collection Device and Conventional Venous Blood Assays: a Secondary Publication in English. Keio J Med. 2018 Jun 25;67(2):26-34. doi: 10.2302/kjm.2017-0009-OA. Epub 2017 Nov 21.
PubMed 29162770Sugimoto S, Tateishi A, Osawa S. [Development of the fingertip blood dilution method for blood cell counting]. Rinsho Byori. 2014 Mar;62(3):235-40. Japanese.
PubMed 24800498
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
- ClinicalTrials.gov ID
- NCT05329493
- Acronym / sponsor ID
- 2022P000271
- Conditions
- Blood
- Keywords
- Blood Draw, Fingerstick Blood Draw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips.
Detailed description
Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers.The fingerstick blood draw has been used as an alternative.
Aiming a less painful, potentially easier alternative we devised a novel that can be applied distally on the digit prior to the blood collection procedure and may provide analgesia through a liquid coolant that is run through tubes in the device to safely cool tissue to achieve numbing. We hypothesize that this device will safely and effectively reduce the pain associated with the fingertip pricks and increase the amount of capillary blood collected.
Multiple punctures with a large lancet were a frequent cause of discomfort among patients.With this new device the discomfort will be reduced by its application followed by the numbness of the finger.
The investigators plan to have 12 patients to complete the study. Subjects must be equal to greater than 18 years old and younger than 60 years older and may be any gender or Fitzpatrick skin type.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling digit device application | Experimental | Device: Cooling digit device applicationDevice: Cooling digit device. The cooling finger device will be applied in the subjects on their right hand. Subjects will serve as their own control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent to participate in the study.
Key exclusion criteria (9 listed)
- • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.
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 |
|---|---|---|
| Cooling digit device applicationAlso: cooling finger deviceCooling digit device will be applied on subject's right hand ( fifth finger). | Device | Cooling digit device application |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: day 1
This scale will be used to record subject pain from the overall pain from the procedure for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst.
2 secondary outcomes
Blood Absorption Via Whatman 903 Filter Paper (Surface Area)
Time frame: Day 1
Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33009571Jankowski CA, Casapao AM, Siller S, Isache C, Cani KV, Claudio AM, Brown M, Milstid B, Feldhammer M. Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients. Am J Clin Pathol. 2021 Feb 11;155(3):412-417. doi: 10.1093/ajcp/aqaa138.
- Background: PubMed 29705575Kertes DA, Kamin HS, Liu J, Bhatt SS, Kelly M. Putting a finger on the problem: Finger stick blood draw and immunization at the well-child exam elicit a cortisol response to stress among one-year-old children. Psychoneuroendocrinology. 2018 Jul;93:103-106. doi: 10.1016/j.psyneuen.2018.04.021. Epub 2018 Apr 22.
- Background: PubMed 29162770Iwasawa H, Nishimura T, Nemoto S, Aikawa N, Watanabe K. Correlation of the Blood Test Results Obtained between Assays Using Microliter-scale Fingertip Blood Samples Collected with a Novel Blood Collection Device and Conventional Venous Blood Assays: a Secondary Publication in English. Keio J Med. 2018 Jun 25;67(2):26-34. doi: 10.2302/kjm.2017-0009-OA. Epub 2017 Nov 21.
- Background: PubMed 24800498Sugimoto S, Tateishi A, Osawa S. [Development of the fingertip blood dilution method for blood cell counting]. Rinsho Byori. 2014 Mar;62(3):235-40. Japanese.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Dieter Manstein, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling digit device application in people with Blood, run by Massachusetts General Hospital at 1 site 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 9 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 13 Feb 2025. 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 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 13 Feb 2025). 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?
Wong-Baker FACES Pain Rating Scale (time frame: day 1). 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 NCT05329493, which also lists 4 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 13 Feb 2025.