MedTrace Logo

Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

NCT05686733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-04-04

No results posted yet for this study

Summary

To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms.

The data from this study will be used to support:

1. EU CE Mark labelling
2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.

Conditions

  • Aneurysms Saccular
  • Aneurysm, Ruptured
  • Aneurysm

Interventions

DEVICE

SEAL Device

Endovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device.

Sponsors & Collaborators

  • Galaxy Therapeutics INC

    lead INDUSTRY

Principal Investigators

  • Boris Pabón, MD · Angiosur

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2024-02-17
Completion
2024-02-17

Countries

  • Colombia

Study Locations

More Related Trials

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 NCT05686733 on ClinicalTrials.gov