A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing

NCT ID: NCT06392269

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-18

Study Completion Date

2024-06-15

Brief Summary

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This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results

Detailed Description

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Conditions

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Serum Analytes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Tasso+

Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture

Tasso+SST

Intervention Type DIAGNOSTIC_TEST

Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.

Interventions

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Tasso+SST

Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 - 85 years
2. Willing and able to provide written informed consent prior to study entry
3. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
4. Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)

Exclusion Criteria

1. Present with abnormal skin integrity or atypical skin health near/on arm collection sites
2. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
3. Laboratory and healthcare personnel.
4. Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tasso Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tasso Research Clinic

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dema Poppa, MS

Role: CONTACT

(206) 822-4186

Facility Contacts

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Brian Massie

Role: primary

206-822-4186

Other Identifiers

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T23-02

Identifier Type: -

Identifier Source: org_study_id

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