Evaluation of Beacon Tip Catheters for medical procedures
Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
This study is testing the safety and performance of new Beacon Tip Catheters during medical procedures to see if they can be approved for use in Europe and other areas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 588 (estimated) |
| Sex | All |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 1 site (Darien, Connecticut) |
| Trial ID | NCT06986954 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the safety and performance of the redesigned Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter during medical procedures. Conducted in the United States, the study will support the re-launch of these devices for regulatory approval in the European Union and potentially other regions. Data will be gathered through the end of the procedure and up to 30 days post-procedure to assess the benefit-risk ratio associated with their use.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing procedures that utilize the Beacon Tip Catheter.
Not a fit: Patients who object to data collection or do not consent to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of catheter-based procedures for patients with vascular conditions.
How similar studies have performed: Other studies involving catheter safety and performance have shown success, indicating a potential for positive outcomes in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter. Exclusion Criteria: * Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to accept the use of an Informed Consent waiver or the data protection notice (if utilized).
Where this trial is running
Darien, Connecticut
- Vascular Breakthroughs — Darien, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Hannah Kay
- Email: hannah.kay@cookmedical.com
- Phone: 800-468-1379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.