Clinical trial · Observational
Obsidio™ Conformable Embolic Registry
A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice
NCT06170619CI-TRIAL-00113117OCCLUDEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Hemorrhage | — | UNRESOLVED | — |
| Hypervascular Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obsidio™ Conformable Embolic | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All subjects
- interventionNames
- Device: Obsidio™ Conformable Embolic
Primary outcomes (2)
- measure
- Primary effectiveness endpoint
- timeFrame
- Immediately following index procedure
- description
- 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.
- measure
- Primary safety endpoint
- timeFrame
- 30 days following index procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.