Obsidio™ Conformable Embolic Registry

Launched by BOSTON SCIENTIFIC CORPORATION · Dec 6, 2023

Keywords

ClinConnect Summary

The Obsidio™ Conformable Embolic Registry, also known as OCCLUDE, is a clinical trial aimed at understanding how effective and safe a treatment called Obsidio™ Conformable Embolic is for patients with certain types of tumors that have a lot of blood supply, or for those experiencing bleeding or hemorrhage. This study is currently recruiting participants who are 18 years or older and are willing to provide their consent. To be eligible, patients must be undergoing or have already undergone a procedure using the Obsidio treatment.

Participants in this study can expect to have their health monitored closely after receiving the treatment, including follow-up visits to assess how well the embolization worked and if there are any side effects. It’s important to note that patients with a very short life expectancy, those who refuse to participate, or those with specific medical conditions may not be eligible for this study. Overall, this trial is an important step in gathering information about a new treatment option for serious health issues related to hypervascular tumors and bleeding.

Gender

ALL

Eligibility 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