Trials / Completed
CompletedNCT04904809
Perclose Multi-Access Duplex Ultrasound (DUS) Study
Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System | The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-05-27
- Completion
- 2022-05-27
- First posted
- 2021-05-27
- Last updated
- 2023-07-20
- Results posted
- 2023-07-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04904809. Inclusion in this directory is not an endorsement.