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RECRUITING NA

Endovascular Engineering ENGULF Study

NCT05597891 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DEVICE Hēlo PE Thombectomy System

Study Locations (19)

California

  • Huntington Hospital — Pasadena
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
  • Torrance Memorial Medical Center — Torrance

Florida

  • Delray Medical Center — Delray Beach
  • Baptist Health Research Institute — Jacksonville
  • HCA Florida Memorial Hospital — Jacksonville

Texas

  • Austin Heart — Austin
  • Baylor Scott & White Research Institute — Dallas
  • UT Health — Houston

Georgia

  • Piedmont Heart — Atlanta
  • Northside Hospital — Atlanta

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Brigham and Women's Hospital — Boston

Tennessee

  • Wellmont Cardiology Services / Ballad Health — Kingsport
  • Tennova Healthcare - Turkey Creek Medical Center — Knoxville

Indiana

  • Indiana University — Indianapolis

Ohio

  • TriHealth Hatton Research Institute — Cincinnati

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2023-01-12
Est. Completion 2025-09-30
Phase NA

Sponsor

Endovascular Engineering

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05597891

The ClinicalTrials.gov registry entry for NCT05597891 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endovascular Engineering, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention — of which Hēlo PE Thombectomy System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05597891 reports 19 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05597891 about?

NCT05597891 is a clinical study titled "Endovascular Engineering ENGULF Study". Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).

What is the current status of trial NCT05597891?

This trial is currently recruiting. It is a NA study. The enrollment target is 181 participants. The study started on 2023-01-12. Estimated completion is 2025-09-30.

What conditions does trial NCT05597891 study?

This clinical trial studies the following conditions: Pulmonary Embolism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05597891?

The interventions under investigation include: Hēlo PE Thombectomy System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05597891?

This trial is sponsored by Endovascular Engineering, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05597891 being conducted?

This trial has 19 study locations across California, Florida, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial