RECRUITING

Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries/regions. The purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.

Official Title

Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study

Quick Facts

Study Start:2025-06-30
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06986954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.
  1. * 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).

Contacts and Locations

Study Contact

Hannah Kay
CONTACT
800-468-1379
hannah.kay@cookmedical.com

Study Locations (Sites)

Vascular Breakthroughs
Darien, Connecticut, 06820
United States

Collaborators and Investigators

Sponsor: Cook Research Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Catheter
  • Beacon
  • Diagnostic imaging
  • Device sizing
  • Beacon tip slip cath

Additional Relevant MeSH Terms

  • Stenosis
  • Bleed Intracranial
  • Stroke
  • TIA
  • Vascular Malformation
  • Pseudoaneurysm