Hypervascular TumorsOCCLUDENCT06170619
Obsidio™ Conformable Embolic Registry
An observational study of Hypervascular Tumors and Bleeding, run by Boston Scientific Corporation at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypervascular Tumors, Bleeding, Hemorrhage
- What is being tested?
- Obsidio™ Conformable Embolic
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 20 sitesUnited States
- Study dates
- 19 Jun 2024to 9 Sep 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo or have undergone embolization with Obsidio™ Conformable Embolic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Albany Medical Center
Albany, New York, 12208
Emory University Hospital
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Hospital
Chicago, Illinois, 60637
Mercy Hospital
Coon Rapids, Minnesota, 55433
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Houston Health Science Center
Houston, Texas, 77030
University of Kansas Hospital
Kansas City, Kansas, 66160
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Mount Sinai Medical Center
New York, New York, 10029
Christiana Hospital
Newark, Delaware, 19718
University Hospital
Newark, New Jersey, 07103
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University of Washington Medical Center
Seattle, Washington, 98195
Barnes Jewish Hosital
St Louis, Missouri, 63110
St. Joseph's Medical Center
Stockton, California, 95204
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
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
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.
- Conditions
- Hypervascular Tumors, Bleeding, Hemorrhage
- Being tested
- Obsidio™ Conformable Embolic
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obsidio™ Conformable EmbolicDevice
Embolization with Obsidio™ Conformable Embolic.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Not described Receives: Device: Obsidio™ Conformable Embolic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness endpoint
The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidio™ Conformable Embolic as assessed via angiography or demonstration of a cast of Obsidio occluding the artery on fluoroscopy or image acquisition immediately following the index procedure.
Measured: Immediately following index procedure
Primary safety endpoint
The primary safety endpoint is freedom from major adverse events defined as non-target embolization events that meet serious adverse event criteria, unintended target organ or soft tissue infarction, vessel perforation/injury and catheter entrapment through 30 days of the index procedure.
Measured: 30 days following index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start19 Jun 2024
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypervascular TumorsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170619
- Sponsor's protocol ID
- S2513
- Acronym
- OCCLUDE
- Status last verified
- May 2026
- First submitted
- 6 Dec 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06170619
- Acronym / sponsor ID
- OCCLUDE / S2513
- Conditions
- Hypervascular Tumors, Bleeding, Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Obsidio™ Conformable Embolic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo or have undergone embolization with Obsidio™ Conformable Embolic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obsidio™ Conformable EmbolicEmbolization with Obsidio™ Conformable Embolic. | Device | All subjects |
Primary outcome
Primary effectiveness endpoint
Time frame: Immediately following index procedure
The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidio™ Conformable Embolic as assessed via angiography or demonstration of a cast of Obsidio occluding the artery on fluoroscopy or image acquisition immediately following the index procedure.
Primary safety endpoint
Time frame: 30 days following index procedure
The primary safety endpoint is freedom from major adverse events defined as non-target embolization events that meet serious adverse event criteria, unintended target organ or soft tissue infarction, vessel perforation/injury and catheter entrapment through 30 days of the index procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypervascular Tumors and Bleeding, run by Boston Scientific Corporation at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness endpoint (time frame: Immediately following index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.