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Endovascular Engineering ENGULF Study

NCT05597891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-04-14

No results posted yet for this study

Summary

Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).

Conditions

Interventions

DEVICE

Hēlo PE Thombectomy System

Treatment with the Hēlo PE Thombectomy System for thromboembolectomy

Sponsors & Collaborators

  • Endovascular Engineering

    lead INDUSTRY

Principal Investigators

  • Andrew Klein, MD · Piedmont Heart

  • Julie Bulman, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2026-03-02
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597891 on ClinicalTrials.gov