Obsidio™ Conformable Embolic Registry

Bleeding Clinical Trial

— OCCLUDE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06170619
• Other study ID #: S2513
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: Stephanie Long
• Phone: 763-229-4482
• Email: stephanie.long[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Hypervascular Tumors

Intervention

Device:
• Obsidio™ Conformable Embolic
Embolization with Obsidio™ Conformable Embolic.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effectiveness endpoint	The primary effectiveness endpoint is technical success which is defined as occlusion of the target vessel after embolization with Obsidio™ Conformable Embolic assessed via angiography immediately following the index procedure	Immediately following index procedure
Primary	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.	30 days following index procedure