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Thrombectomy Device

Viper Catheter System for Pulmonary Embolism (ENGULF Trial)

N/A

Recruiting

Led By Andrew Klein, MD

Research Sponsored by Endovascular Engineering

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours following the procedure

Awards & highlights

ENGULF Trial Summary

This trial tested a new catheter system to remove blood clots from the lungs caused by PE.

Who is the study for?

This trial is for adults aged 22 to 90 with acute submassive pulmonary embolism, stable blood pressure and heart rate, and evidence of a blockage in the lung arteries. They must be able to consent and have not used certain blood thinners recently. Excluded are those with severe heart issues, recent major surgery or trauma, extreme obesity, or conditions affecting life expectancy.Check my eligibility

What is being tested?

The study tests the Viper Catheter System's safety and feasibility for removing clots from lung arteries in patients with a type of lung blockage called acute submassive pulmonary embolism. It's an initial evaluation using this novel device on eligible participants.See study design

What are the potential side effects?

Potential side effects may include bleeding complications, allergic reactions to device materials or contrast agents used during the procedure, damage to blood vessels where the catheter is inserted, irregular heartbeat risks due to catheter navigation through heart chambers.

ENGULF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours following the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours following the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours following the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Performance Objective

Primary Safety Objective

Secondary outcome measures

Secondary Performance Objective

ENGULF Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational DeviceExperimental Treatment1 Intervention

The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 131 subjects, to yield 100 evaluable subjects at 48 hours post procedure.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Endovascular EngineeringLead Sponsor

Andrew Klein, MDPrincipal InvestigatorPiedmont Heart

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to elderly individuals for this clinical study?

"The strict inclusion criteria for this medical trial is between 22 and 90 years old. There are 7 clinical trials specifically designed to accommodate minors, while those aged 65 or over have access to 78 alternative studies."

Answered by AI

Who meets the requirements to partake in this medical study?

"The criteria for entry into this clinical trial requires that patients have been diagnosed with pulmonary embolism and are between the ages of 22 and 90. There is a need to recruit 25 people in total."

Answered by AI

How many sites are undertaking this clinical investigation?

"This clinical trial is being conducted across 6 different sites, including those located in Jacksonville, Boston and Ann Arbor. To make the experience more convenient for participants, it's advised to choose a location closest to you."

Answered by AI

How many participants are currently being enrolled into this research project?

"Endovascular Engineering is seeking 25 participants that meet the study's eligibility requirements. This trial will be run at HCA Florida Memorial Hospital in Jacksonville, and Brigham and Women's Hospital in Boston."

Answered by AI

Is the research recruitment phase of this experiment still open?

"Affirmative. According to records posted on clinicaltrials.gov, this trial is still searching for study participants after it was first published on December 1st 2023 and last updated on May 5th 2023. At the moment they are seeking 25 individuals between 6 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endovascular Engineering ENGULF Study

2023. "Endovascular Engineering ENGULF Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597891.

All > Pulmonary Embolism