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SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

NCT05880680 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-04-04

No results posted yet for this study

Summary

Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.

Conditions

  • Aneurysm
  • Aneurysm, Ruptured

Interventions

DEVICE

SEAL Device

Using standard interventional endovascular techniques, the device is navigated via the push wire delivery system through compatible neurovascular microcatheters to the aneurysm lumen or target site. The device is positioned into its target aneurysm lumen and is electrically detached by the operator with a hand-held, battery-powered detachment handle designed specifically for the SEAL Embolization System.

Sponsors & Collaborators

  • Galaxy Therapeutics INC

    lead INDUSTRY

Principal Investigators

  • Osama Zaidat, MD, MS · Mercy Health, OH

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2026-12-31
Completion
2030-06-15

Countries

  • Colombia
  • New Zealand
  • Pakistan
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05880680 on ClinicalTrials.gov