Clinical Trial: INVEST: Minimally Invasive Endoscopic Surgery vs. Medical Management in Supratentorial Intraparenchymal Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)

Brief 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.

Detailed Summary:

Objective: 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.

Study Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers.

Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Apollo system.

Indication: : The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials.


Sponsor: J. Mocco

Current Primary Outcome:

  • Rate of recruitment [ Time Frame: 730 days ]
    following first patient enrollment
  • Rate of successful follow up obtainment [ Time Frame: 180 days ]
    Follow up of patients


Original Primary Outcome:

  • modified Rankin score (mRS) [ Time Frame: 180 days ]
    disability assessed via the modified Rankin score (mRS)
  • Rate of mortality [ Time Frame: 30 days ]


Current Secondary Outcome:

  • Stroke Impact Scale - Mobility [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all
  • Stroke Impact Scale - ADLs [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all
  • EQ-5D-5L [ Time Frame: 180 days ]
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. scored as 1 = no problem to 5 = severe problem
  • Length of hospital stay [ Time Frame: average of 180 days ]
    number of days of hospital stay
  • Clinical Efficacy Endpoint [ Time Frame: 180 days ]
    Global disability assessed via the modified Rankin score (mRS), categorized as either mRS < 3 or mRS > 3
  • Rate of surgical success [ Time Frame: 180 days ]
    Technical Efficacy Endpoint
  • Hemorrhage volume [ Time Frame: 180 days ]
    Predominantly or Only ICH: Reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan
  • MGraeb score [ Time Frame: Day 7 ]
    Predominantly or Only IVH: mGraeb score of < 5 on day 7 CT scan
  • Rate of mortality [ Time Frame: 90 days ]
    Safety Endpoint


Original Secondary Outcome:

  • Stroke Impact Scale - Mobility [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all
  • Stroke Impact Scale - ADLs [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all
  • EQ-5D-5L [ Time Frame: 180 days ]
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. scored as 1 = no problem to 5 = severe problem
  • Length of hospital stay [ Time Frame: average of 180 days ]


Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: January 11, 2016
Date Started: May 1, 2017
Date Completion: January 2019
Last Updated: April 10, 2017
Last Verified: April 2017