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Registry for patients undergoing embolization with Obsidio™ Conformable Embolic

A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice

Observational Boston Scientific Corporation · NCT06170619

This study is collecting information from patients who are getting a specific type of treatment for tumors or bleeding to see how well it works and if it's safe.

Quick facts

Study typeObservational
Enrollment125 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations20 sites (Phoenix, Arizona and 19 other locations)
Trial IDNCT06170619 on ClinicalTrials.gov

What this trial studies

This observational registry collects data from patients who are undergoing embolization procedures using the Obsidio™ Conformable Embolic. It aims to evaluate the effectiveness and safety outcomes of this treatment in patients with hypervascular tumors and those experiencing bleeding or hemorrhage. The registry is multi-center and includes participants from various locations across the United States. Patients will be monitored for their compliance with protocol requirements and follow-up evaluations.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who are undergoing or have undergone embolization with Obsidio™ Conformable Embolic.

Not a fit: Patients with a life expectancy of less than 30 days or those with contraindications to receiving Obsidio™ will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of Obsidio™ Conformable Embolic for treating hypervascular tumors and managing bleeding.

How similar studies have performed: Other studies involving embolization techniques have shown promising results, suggesting that this approach may be effective, although the specific use of Obsidio™ is being evaluated in this novel registry.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient is ≥ 18 years of age
* Signed informed consent\*
* Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
* Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure

Exclusion Criteria:

* Patient has a life expectancy \< 30 days
* Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
* Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
* Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Where this trial is running

Phoenix, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypervascular TumorsBleedingHemorrhage
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.