Obsidio™ Conformable Embolic Registry

About

Brief 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.

Study Type

Observational

Phase

Phase 4

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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

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