Obsidio™ Conformable Embolic Registry (OCCLUDE)

Boston Scientific

Status: Enrolling

Conditions: Hypervascular Tumors; Hemorrhage; Bleeding

Treatments: Device: Obsidio™ Conformable Embolic

Study type: Observational

Funder types: Industry

Identifiers

NCT06170619

S2513

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 1 patient group

All subjects

Treatment:

Device: Obsidio™ Conformable Embolic