No Disease or Condition is Being StudiedPRPNCT07041918
Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma
An observational study of No Disease or Condition is Being Studied, run by Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- No Disease or Condition is Being Studied
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2025to 31 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,
Who may be able to join
- 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.
Who cannot join
- Platelet dysfunction syndrome,
- Critical thrombocytopenia,
- Hemodynamic instability,
- Septicemia,
- Local infection at the site of the procedure,
- Autoimmune diseases,
Show all 25Show fewer
- 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,
- Platelet count below 105/μl,
- Those under immunosuppressive therapy,
- Any condition or disease detected during the medical interview/physical examination that, in the opinion of the researcher or designated personnel, would make the volunteer unsuitable for the study, put them at unnecessary risk, or interfere with the volunteer's ability to complete the study,
- Clinically significant deviation from normal findings in the physical examination, including vital signs,
- Patients planning pregnancy or not using contraception,
- Patients using hormonal contraceptive methods to prevent pregnancy,
- Breastfeeding women,
- Poor venous access for blood sampling,
- Plasma or blood donation within the last 2 months,
- It is recommended to select patients who do not use tobacco products during the study, as it is considered that it may affect the product's performance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medical Point Hastanesi Klinik Araştırmalar Merkezi
Izmir, Karşıyaka, 35575
About this study
Official title: Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma: A Prospective, Observational Medical Device Study (PMCF)
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.
Read the detailed description
The study is a post-market clinical follow-up (PMCF) study aimed at proving the effectiveness and safety of PRP tubes that are already CE (European Conformity) certified and released on the market. After the eligibility assessment during screening and obtaining the written informed consent form, the demographic information and medical history of eligible volunteers will be recorded on a paper case report form.
The analysis conducted using the G-Power power test calculated that the number of patients to be included in the study is 194.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, platelet (PLT) count will be performed on the obtained plasma, and the concentration increase relative to whole blood will be analyzed.
Screening Day (Day 1):
Volunteers will undergo a medical history review to check eligibility for inclusion in the study.
Analysis Day (Day 1):
A single blood sample will be collected for platelet (hemogram) testing, and for women of reproductive age, a beta HCG (human chorionic gonadotropin) test will be conducted.
Platelet (PLT) count will be performed on the plasma obtained from the blood sample collected in the PRP tubes.
The concentration increase in the resulting plasma will be analyzed in relation to whole blood.The PRP results of volunteers who do not meet the inclusion criteria based on hemogram test results or who are pregnant will not be included in the study.
- Conditions
- No Disease or Condition is Being Studied
- Being tested
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1: Blood will be taken on the same day and sent for analysis for counting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start29 May 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Disease or Condition is Being StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Recep Selim Şentürk, MD, Principal investigator, Medical Point Hastanesi Klinik Araştırmalar Merkezi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041918
- Sponsor's protocol ID
- 0.PRT.KGV.002
- Acronym
- PRP
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma: A Prospective, Observational Medical Device Study (PMCF)
- ClinicalTrials.gov ID
- NCT07041918
- Acronym / sponsor ID
- PRP / 0.PRT.KGV.002
- Conditions
- No Disease or Condition is Being Studied
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.ŞIndustry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a post-market clinical follow-up (PMCF) study aimed at proving the effectiveness and safety of PRP tubes that are already CE (European Conformity) certified and released on the market. After the eligibility assessment during screening and obtaining the written informed consent form, the demographic information and medical history of eligible volunteers will be recorded on a paper case report form.
The analysis conducted using the G-Power power test calculated that the number of patients to be included in the study is 194.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, platelet (PLT) count will be performed on the obtained plasma, and the concentration increase relative to whole blood will be analyzed.
Screening Day (Day 1):
Volunteers will undergo a medical history review to check eligibility for inclusion in the study.
Analysis Day (Day 1):
A single blood sample will be collected for platelet (hemogram) testing, and for women of reproductive age, a beta HCG (human chorionic gonadotropin) test will be conducted.
Platelet (PLT) count will be performed on the plasma obtained from the blood sample collected in the PRP tubes.
The concentration increase in the resulting plasma will be analyzed in relation to whole blood.The PRP results of volunteers who do not meet the inclusion criteria based on hemogram test results or who are pregnant will not be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (25 listed)
- Platelet dysfunction syndrome,
- Critical thrombocytopenia,
- Hemodynamic instability,
- Septicemia,
- Local infection at the site of the procedure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Increasing platelet concentration
Time frame: Day 1: Blood will be taken on the same day and sent for analysis for counting.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Recep Selim Şentürk, MD principal investigator
Medical Point Hastanesi Klinik Araştırmalar Merkezi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Disease or Condition is Being Studied, run by Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing platelet concentration (time frame: Day 1: Blood will be taken on the same day and sent for analysis for counting.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.