Obsidio™ Conformable Embolic Registry

ID#: NCT06170619

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: June 19, 2024

End Date: June 01, 2025

Contact Information:
Stephanie Long
763-229-4482
Krista Asmus, MPH
952-356-9553
Summary: OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.
Eligibility:

Inclusion Criteria:

- Age ≥ 18 years old

- Patient has the ability to comprehend and willingness to sign the informed consent form. Patients being treated for control of bleeding /hemorrhage unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hrs. of the index procedure

- 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 visit

Exclusion Criteria:

- Patient refuses participation

- 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

- Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels
Find a Clinical Trial Find Cancer Clinical Trials