Status:
COMPLETED
A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Blood
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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.
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 sta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- • 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
- 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.
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05329493
Start Date
June 21 2023
End Date
November 8 2024
Last Update
February 13 2025
Active Locations (1)
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1
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, United States, 02114