A Novel Cooling Device for Pain Management During Fingerstick Blood Draw

NCT05329493 | Completed Results FDA Device

• 1 other identifier: 2022P000271
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood

Keywords

Blood Draw; Fingerstick Blood Draw

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1

Secondary Outcomes (2)

• Blood Absorption Via Whatman 903 Filter Paper (Surface Area)

  Day 1

• Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)

  Day 1

Study Arms (1)

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.

Device: Cooling digit device application

Interventions

Cooling digit device application DEVICE

Cooling digit device will be applied on subject's right hand ( fifth finger).

Also known as: cooling finger device

Cooling digit device application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 33009571 BACKGROUND

• Kertes 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.

  PMID: 29705575 BACKGROUND

• Iwasawa 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.

  PMID: 29162770 BACKGROUND

• Sugimoto 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.

  PMID: 24800498 BACKGROUND

Results Point of Contact

• Title: Dr. Dieter Manstein
• Organization: Massachusetts General Hospital

dmanstein@mgh.harvard.edu

617-726-4893

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 15, 2022
• Study Start: June 21, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)