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To study the clinical evaluation of bio specimen device

An open label clinical evaluation to objectively assess and measure functionality of bio-specimen microsampler device -BioSampler

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048267
Enrollment
40
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NA: NA

Sponsors

Iota Diagnostic Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy Men and women volunteers are chosen in a ratio of 1:1 aged > 35 and 2.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure. 3.Having healthy skin on the test area as assessed by dermatological examination and donâ??t have a history of allergy. 4.Subjects who are compliant with the study

Exclusion criteria

Exclusion criteria: 1.Scars, excessive terminal hair, or tattoos on the studied area. 2.Dermatological infection/pathology on level of studied area. 3.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 4.Chronic illness which may influence the outcome of the study. 5.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).

Design outcomes

Primary

MeasureTime frame
Laboratory confirmation and analysis of the samples received from the clinical site.Timepoint: On first visit

Secondary

MeasureTime frame
Laboratory confirmation of the sample viability for different volumetric capacitiesTimepoint: On the visit

Countries

India

Contacts

Public ContactMeena Dalal

Trial Guna Pvt Ltd

meena@trialguna.com9972636265

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026