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INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage

NCT02654015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-22

Study results available
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Summary

The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Conditions

  • Intracranial Hemorrhage

Interventions

DEVICE

Apollo MIES

Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.

OTHER

Medical Management

Subjects will receive best medical management for intracranial hemorrhage

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • University at Buffalo

    collaborator OTHER

  • J. Mocco

    lead OTHER

Principal Investigators

  • J Mocco, MD, MS · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2022-09-07
Completion
2022-09-07
FDA Device
Yes

Countries

  • United States

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 NCT02654015 on ClinicalTrials.gov