Clinical trial NCT06170619: Obsidio™ Conformable Embolic Registry
Official title: A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypervascular Tumors
Bleeding
Hemorrhage
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo or have undergone embolization with Obsidio™ Conformable Embolic

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.


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

Primary outcomes:
measure: Primary effectiveness endpoint
timeFrame: Immediately following index procedure
measure: Primary safety endpoint
timeFrame: 30 days following index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish Hosital
state: Missouri
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: