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Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma

NCT07041918 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2025-11-28

No results posted yet for this study

Summary

Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.

In addition to the hemogram and pregnancy test to be performed on the volunteers in this study, an additional tube (approximately 8 ml (±10%) for the VACUSERA® Single PRP Tube or approximately 7 ml (±10%) for the VACUSERA® Single Gel PRP Tube) will be used to obtain platelet-rich plasma (PRP). After centrifugation of the PRP tubes, the platelet (PLT) count in the resulting plasma will be analyzed, and the concentration increase in relation to whole blood will be evaluated.

Conditions

  • No Disease or Condition is Being Studied

Interventions

DEVICE

The study is entirely designed to analyze product performance (analyze only results from whole blood and derived from the PRP tubes), and no interventions will be performed.

The study will evaluate and analyze only the results obtained from whole blood in the hemogram test and the results derived from the PRP tubes. The main objective is to measure the performance of the Vacusera PRP Tube and Vacusera PRP Tube with Gel in obtaining platelet-rich plasma. The study is entirely designed to analyze product performance, and no interventions will be performed.

Sponsors & Collaborators

  • Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş

    lead INDUSTRY

Principal Investigators

  • Recep Selim Şentürk, MD · Medical Point Hastanesi Klinik Araştırmalar Merkezi

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041918 on ClinicalTrials.gov