The SING IVL study, officially known as the Singapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study, is currently recruiting participants for its clinical trial. Focused on advancing the use of medical devices in cardiovascular care, the study is sponsored by the National Heart Centre Singapore and Biosensor Interventional Technologies Pte Ltd. Professionals engaged in clinical, regulatory, and quality domains will find this development particularly relevant as it seeks to pave new pathways in vascular treatment research.
What is the SING IVL study about?
The SING IVL trial is an advanced clinical study that investigates the application of intravascular lithotripsy (IVL) technology in cardiovascular diseases. The primary intervention involves the use of an innovative medical device designed to improve outcomes for patients with vascular conditions. By targeting calcified arterial deposits, IVL devices use acoustic shockwaves to restore arterial flexibility, potentially optimizing patient care and addressing a pressing clinical need.
Why is IVL technology significant?
IVL technology represents a groundbreaking method that combines mechanical precision with the therapeutic delivery of shockwaves. This approach differs from traditional treatments by targeting hardened arteries while minimizing damage to surrounding tissues. The study aims to provide robust data on performance and safety, supporting regulatory pathways.
How does it address cardiovascular disease?
Cardiovascular diseases remain a leading cause of morbidity worldwide, making effective and safe interventions essential. SING IVL focuses on calcified coronary lesions, which often pose challenges during conventional angioplasty procedures. The trial’s findings could inform future treatment protocols by validating IVL devices for clinical use.
What benefits could this study provide?
Potential benefits include reduced procedural complications, improved arterial compliance, and enhanced long-term patient outcomes. These advantages align with the overarching goals of medical research to increase device efficacy and ensure patient safety under stringent regulatory scrutiny.
Who can participate?
The SING IVL study is actively recruiting participants as of December 2025. Specific inclusion and exclusion criteria for participants are typically defined by the study coordinators, emphasizing patient suitability and adherence to medical ethics. Interested individuals or healthcare providers are encouraged to inquire directly through the sponsor’s official channels.
Sponsors include the National Heart Centre Singapore and Biosensor Interventional Technologies Pte Ltd, both recognized entities advancing cardiovascular research and technology.
Frequently Asked Questions
- What is intravascular lithotripsy (IVL)?
IVL is a medical device technology that uses acoustic shockwaves to treat calcified arterial deposits, restoring flexibility and improving blood flow. - Is the SING IVL study limited to Singapore?
While the study is based in Singapore, its findings could have global implications for cardiovascular care. - How can I learn more about participant criteria?
Contact the study’s sponsors for specific enrollment information or consult the trial listing on ClinicalTrials.gov at the provided link. - Are there risks associated with IVL procedures?
All medical interventions carry risks. Clinical trials like SING IVL focus on balancing risk and benefit while adhering to safety guidelines.
Why is this study important?
The SING IVL study has the potential to reshape how calcified coronary lesions are treated, contributing to better patient outcomes and enhanced device safety profiles. Regulatory and clinical teams should monitor this study for insights into emerging cardiovascular interventions.
Disclaimer
This information is intended for professionals in clinical, quality, and regulatory fields. It does not constitute legal advice. Readers should consult official regulatory sources for specific guidance.
For more details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07259239?term=medical+device