Regulatory Alert: Dual Protocol Trial of Extracorporeal Shock Wave Therapy for Patellar Tendinitis Under Clinical Evaluation

Publication date context: February 11, 2026. A new ClinicalTrials.gov entry from Sun Yat Sen Memorial Hospital of Sun Yat Sen University describes a trial testing extracorporeal shock wave therapy for patellar tendinitis. The trial compares two ESWT protocols: one combining the patellar tendon procedure with a Center of Coordination Point and the other using ESWT only on the patellar tendon. The sponsor is Sun Yat Sen Memorial Hospital of Sun Yat Sen University and recruitment is listed as recruiting. This report highlights what the entry reveals and what it may mean for device manufacturers, clinical teams, and regulatory observers.

What is new in this trial?

The ClinicalTrials.gov record NCT07401758 from Sun Yat Sen Memorial Hospital shows two ESWT protocols being tested for patellar tendinitis. The first protocol uses ESWT on the patellar tendon in combination with Center of Coordination Point and the second protocol uses ESWT on the patellar tendon alone. The recruiting status indicates the study is actively seeking participants. The entry lists the sponsor name and the trial location. This information helps stakeholders map potential device use contexts and regulatory oversight.

External link: ClinicalTrials.gov entry NCT07401758.

How is the trial designed?

The entry describes two procedures and suggests a parallel set of interventions. The trial compares a combination approach with a solo tendon procedure. The exact design details such as randomization, sample size, endpoints and duration are not provided in the source text. The trial focuses on safety and potential efficacy signals of extracorporeal shock wave therapy applied to the patellar tendon.

What is Center of Coordination Point?

The reference to Center of Coordination Point implies an additional procedural element included with the therapy. The source text does not elaborate on the method or measurement of this point. Regulators will expect clear definitions of operational steps and device settings in any final protocol.

What safety and regulatory considerations apply?

Extracorporeal shock wave therapy is a device based intervention used for musculoskeletal indications. The entry indicates the trial will scrutinize both efficacy and safety signals as part of the evaluation. Regulators will look for complete risk disclosures, device performance parameters, operator training requirements and post market surveillance plans if the therapy progresses to broader use. Device sponsors should plan for data collection that aligns with MDR Annex XIV expectations for devices that are tested in clinical studies.

What does this mean for practice and policy?

Clinicians may watch for updates on whether adding the Center of Coordination Point to the tendon therapy confers benefit. If efficacy signals emerge, the combination approach could influence how practitioners integrate ESWT into treatment pathways for patellar tendinitis. For device developers, the trial signals continued interest in ESWT devices for knee conditions and in supporting features that can be used with coordination points. Regulators will seek rigorous study designs, transparent reporting and timely safety monitoring as these protocols evolve.

FAQ

  1. What is the focus of the trial? The trial assesses two ESWT protocols for patellar tendinitis.
  2. What are the two arms? One uses ESWT on the patellar tendon with Center of Coordination Point; the other uses ESWT on the patellar tendon alone.
  3. Who sponsors? Sun Yat Sen Memorial Hospital of Sun Yat Sen University.

Conclusion

In summary, the entry for NCT07401758 shows a two arm ESWT evaluation for patellar tendinitis. The presence of a Center of Coordination Point suggests an additional procedural element under study. Regulators and industry observers should track protocol details as they become available, including endpoints, safety data and operator requirements.

Disclaimer

The content is provided for professional and regulatory purposes and is not legal advice. It should not be treated as a legal interpretation of regulatory requirements. Always consult qualified counsel or the official regulatory guidance for your jurisdiction.

For full information about the announcement, see the link below.

https://clinicaltrials.gov/study/NCT07401758?term=medical+device

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