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NCT05127915 · ClinicalTrials.gov registry record · NA
US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
A NA study of Pulmonary Embolism, sponsored by Adient Medical.
- Active
- Registry status
- NA
- Development phase
- 854
- Enrollment target
- 2
- Study locations
NCT05127915 is a NA study of Pulmonary Embolism that is active but no longer recruiting, run by Adient Medical. The registered enrollment target is 854 participants, below the 3,041-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05127915, a NA study of Pulmonary Embolism, is active but no longer recruiting, sponsored by Adient Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 854 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of the study is to evaluate the safety and efficacy of the Adient absorbable filter for the prevention of pulmonary embolism (PE: blood clot in the lungs). PE claims the lives of over 100,000 Americans each year, more than breast cancer, traffic fatalities and HIV combined. Pharmaceutical anticoagulation (blood thinners) that reduce blood clot formation represent the standard of care for treating patients at risk for PE. However, for people who are temporarily unable to use anticoagulants, such as those who have suffered major trauma or those who are scheduled for surgical procedures, inferior vena cava (IVC) filters are used to help protect against PE. These blood filters prevent large blood clots that originate in the deep veins of the legs (deep vein thrombosis (DVT)) from reaching your lungs causing a potentially life-threatening PE. Conventional metal IVC filters have been proven effective at reducing the incidence of PE, however, most require retrieval. If not retrieved within a timely manner (months), they can perforate the IVC, impale nearby organs with their barbed struts, and cause blood clots. In contrast, the Adient absorbable filter traps blood clots similar to conventional metal IVC filters, but following the 8 week protection period, the filter itself breaks down into carbon dioxide and water. Hence no filter retrieval is required and complications are less likely due to the shortened indwell time. Once blood clots are trapped in the absorbable filter, the body's thrombolytic enzymes dissolve the clots within weeks while the filter itself resorbs in 6 to 8 months. The absorbable filter is braided from absorbable suture that has been proven safe over 4 decades. The question being addressed with the randomized controlled trial portion is whether the placement of the absorbable filter in addition to current best practice PE prevention (sequential compression machines, compression stockings, and anticoagulants when indicated) significant
Conditions Studied
Interventions
- DEVICE Adient absorbable filter + best practice VTE prophylaxis
- DEVICE best practice VTE prophylaxis
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Indiana
- IU Health University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 854 participants |
| Start Date | 2023-01-27 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05127915
The ClinicalTrials.gov registry entry for NCT05127915 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 854 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,041-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (72% lower). The listed sponsor is Adient Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions - of which Adient absorbable filter + best practice VTE prophylaxis is the first listed.
NCT05127915 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Indiana.
Frequently Asked Questions
What is clinical trial NCT05127915 about?
NCT05127915 is a clinical study titled "US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism". The objective of the study is to evaluate the safety and efficacy of the Adient absorbable filter for the prevention of pulmonary embolism (PE: blood clot in the lungs). PE claims the lives of over 100,000 Americans each year, more than breast cancer, traffic fatalities and HIV combined. Pharmaceut...
What is the current status of trial NCT05127915?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 854 participants. The study started on 2023-01-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05127915 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT05127915?
The interventions under investigation include: Adient absorbable filter + best practice VTE prophylaxis (DEVICE), best practice VTE prophylaxis (DEVICE).
Who is sponsoring clinical trial NCT05127915?
This trial is sponsored by Adient Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05127915 being conducted?
This trial has 2 study locations across Colorado, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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