Trials / Completed
CompletedNCT05597891
Endovascular Engineering ENGULF Study
A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Endovascular Engineering · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hēlo PE Thombectomy System | Treatment with the Hēlo PE Thombectomy System for thromboembolectomy |
Timeline
- Start date
- 2023-01-12
- Primary completion
- 2026-03-02
- Completion
- 2026-03-30
- First posted
- 2022-10-28
- Last updated
- 2026-04-14
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05597891. Inclusion in this directory is not an endorsement.