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

NCT07041918 | Completed

• 1 other identifier: 0.PRT.KGV.002
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Increasing platelet concentration

  Approximately 8 ml (±10%) of blood will be collected to the PRP Tubes and approximately 7 ml (±10%) to the PRP Tube with Gel, and platelet (PLT) count will be performed on the obtained plasma, with the concentration increase relative to whole blood analyzed.

  Day 1: Blood will be taken on the same day and sent for analysis for counting.

Interventions

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. DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,

You may qualify if:

• Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,
• Body Mass Index (BMI) between 18 and 32 during screening,
• No pregnancy or risk of pregnancy for women,
• Willing to participate and provide written informed consent and comply with the study restrictions,
• Must not have participated in any clinical trial within 2 months prior to the start of the study,
• Must be able to communicate with the researcher or authorized personnel.

You may not qualify if:

• Platelet dysfunction syndrome,
• Critical thrombocytopenia,
• Hemodynamic instability,
• Septicemia,
• Local infection at the site of the procedure,
• Autoimmune diseases,
• History of chronic infections,
• Chronic liver pathology,
• Patients receiving anticoagulant/antiplatelet therapy,
• Use of NSAIDs (except for paracetamol) in the last 7-10 days,
• History of alcohol and/or drug addiction,
• Corticosteroid use,
• Fever or illness in the past week,
• Cancer (especially blood and bone cancers),
• Hemoglobin (HGB) levels below 10 g/dl or above 16.5 g/dl in men and 16 g/dl in women,

Sponsors & Collaborators

• Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş: lead

Study Sites (1)

Medical Point Hastanesi Klinik Araştırmalar Merkezi

Izmir, Karşıyaka, 35575, Turkey (Türkiye)

Location

Study Officials

• Recep Selim Şentürk, MD

  Medical Point Hastanesi Klinik Araştırmalar Merkezi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: May 29, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)