Regulatory update on a completed trial evaluating platelet rich plasma with conventional physiotherapy for shoulder impingement, outlining interventions, sponsor, protocol context, and trial status.
Istinye University in Turkey sponsored the study registered as NCT07410208. The record lists Platelet Rich Plasma as a drug intervention and Conventional Physiotherapy as an additional treatment, with an IPRP PT Study Protocol also noted. The sponsor and the status indicate the project has moved through completion, with details available on ClinicalTrials.gov.
What changed in the regulatory landscape? The entry demonstrates a combination therapy approach to shoulder impingement that uses autologous platelet material together with physical rehabilitation within a defined protocol. The IPRP PT Protocol mention points to a structured plan intended to guide safety assessments and the planned integration of PRP with physiotherapy in a regulatory context. While no efficacy outcomes are provided in this excerpt, the registration and protocol presence support ongoing evaluation by a regulatory and clinical research community.
In this article we summarize the essential facts for professionals evaluating or monitoring such trials. The trial interventions are PRP as a drug and a conventional physiotherapy program, with a separate protocol item indicating an integrated PRP plus physiotherapy approach. The source text also identifies Istinye University as sponsor and indicates that the study is Completed, which is relevant for tracking regulatory status and potential publication activity. The ClinicalTrials.gov link is provided for stakeholders seeking primary documentation.
In this article
- What is this study about?
- How is the study designed and what interventions are involved?
- Who sponsors and what is the status?
- What does this mean for regulation and patient care?
- FAQ
- Conclusion
- Disclaimer
- Announcement
What is this study about?
The record pertains to shoulder impingement syndrome and includes Platelet Rich Plasma as a drug intervention alongside a conventional physiotherapy program. The study also references an IPRP PT Protocol as part of the intervention plan. The sponsor is Istinye University and the project is listed as completed. The ClinicalTrials.gov entry provides the primary documentation and identifier NCT07410208.
What is Platelet Rich Plasma and how is it being used in this context is described by the study record as a drug intervention. The record lists PRP together with a physiotherapy program and notes the existence of a study protocol that suggests an integrated approach to treatment. Although the findings are not presented in this excerpt, the combination signals a focus on multimodal strategies for impingement management.
How is the study designed and what interventions are involved?
The interventions listed include a drug component PRP and an additional component described as Conventional Physiotherapy Program. An IPRP PT Study Protocol is mentioned as part of the study plan. The sponsor is Istinye University and the status is Completed. The entry on ClinicalTrials.gov provides a registry record and a unique identifier NCT07410208 for reference and verification.
The description implies a multimodal approach that pairs a biologic product with rehabilitation therapy. In regulation terms this raises questions about the regulatory status of PRP products and their use in combination with rehabilitation programs within a structured protocol. Stakeholders should monitor any published results or regulatory updates that may arise from this trial.
Who sponsors and what is the status?
Sponsor Istinye University is identified in the record. The status is Completed, which means the trial has finished enrollment and data collection as of the record. This status is relevant for regulators and institutions tracking trial activity and for patients who may later access results or publications related to this work. The ClinicalTrials.gov link serves as the primary source for verification of the record details.
As a university sponsored trial the work may feed into academic and regulatory discussions about the safety and use of PRP when combined with physiotherapy for shoulder impingement, even in the absence of reported outcomes in this brief excerpt.
What does this mean for regulation and patient care?
From a regulatory perspective the combination of a biologic product PRP with a physiotherapy program within a defined protocol calls for careful consideration of safety, intended use and labeling. The IPRP PT Protocol mention indicates a plan to standardize how the therapy is delivered and monitored. Regulators and clinicians should watch for any published results, adverse event reports, or updates to the trial page that would clarify efficacy signals and risk management. The record also points to a legitimate research path in which academic institutions collaborate with clinical practice to evaluate multimodal treatment approaches for shoulder impingement.
For patients and clinicians this information highlights the existence of a registered trial exploring a multimodal therapy option. While no outcome data are provided here, the record supports ongoing evaluation by the research community and the potential for future guidance should results become available.
FAQ
- What condition is studied? The study targets shoulder impingement syndrome.
- What interventions are used? Platelet Rich Plasma as a drug and a conventional physiotherapy program, with a protocol mentioned for integration.
- Who conducts the trial? Istinye University is listed as sponsor.
- What is the trial status? The record shows Completed.
- Where can the primary documentation be found? The ClinicalTrials.gov entry for NCT07410208 is provided in the source text and link.
Conclusion
The trial record shows a completed study of PRP with physiotherapy for shoulder impingement under a defined protocol. Regulatory and clinical practice communities may monitor for subsequent results or publications to inform safety and potential practice guidance. Stakeholders should verify the official record for any updates and consult the linked ClinicalTrials.gov page for primary documentation.
Disclaimer
This article presents regulatory information for professional readers. It is not legal advice. It is intended for informational and regulatory purposes only. No medical recommendations are offered here. Consult your regulatory team for jurisdiction specific guidance.
Announcement
https://clinicaltrials.gov/study/NCT07410208?term=medical+device