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US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
NCT05127915 · View on ClinicalTrials.gov ↗
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. 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 854 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adient Medical, 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 2 interventions — of which Adient absorbable filter + best practice VTE prophylaxis 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: NCT05127915 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Colorado, Indiana. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05127915?
This trial is sponsored by Adient Medical, 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 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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