Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

NCT03414307 | Withdrawn FDA Device

• 1 other identifier: 0717-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly. Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant neurologic dysfunction. In the past, medical management (e.g., control of hypertension, reversal of antiplatelet or anticoagulants) had been the most effective treatment for these patients, given the morbidity and mortality associated with open surgical treatment for evacuation of ICH. However, recent trials have demonstrated that minimally invasive stereotactic neurosurgical procedures to evacuate ICH are safe and result in improved outcomes for these patients. Initial attempts to evaluate the efficacy of surgical evacuation of ICH found no significant difference between medical management and standard craniotomy for surgical evacuation. Indeed, open surgery was often discouraged for these patients due to the significant morbidity and mortality associated with the surgical procedure itself. However, research has demonstrated that minimally invasive, image guided stereotactic frame-based and frameless methods are effective and safe for the placement of catheters for clot aspiration and fibrinolytic therapy of ICH in the basal ganglia and other deep seated regions. Larger randomized controlled trials have demonstrated that these minimally invasive approaches also offer clinical benefit for these patients.

Conditions

Intracerebral Hematoma

Outcome Measures

Primary Outcomes (1)

• Hematoma volume reduction

  Percentage of hematoma evacuation identified by CT scan

  Day 1 to Day 4 post operative

Secondary Outcomes (2)

• Linear measurement of accuracy

  Day 0

• Functional Outcomes measured by modified Rankin Scale (mRS) for neurologic disabilities

  Baseline, 3-month, 6-month and 1-year post-operative

Study Arms (1)

Intracerebral hemorrhage

EXPERIMENTAL

Patients with ICH meeting inclusion/exclusion criteria undergo ROSA stereotactic robot-assisted intracerebral catheter placement to evacuate intracerebral or intracranial hemorrhage

Procedure: Intracerebral catheter placement; Device: Robot-assisted intracerebral catheter

Interventions

Intracerebral catheter placement PROCEDURE

Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage

Also known as: Stereotactic catheter placement

Intracerebral hemorrhage

Robot-assisted intracerebral catheter DEVICE

ROSA is a robotic device with trajectory planning software that can be used to aid in planning multiple trajectories to large, irregular clots, and aids in navigating into and out of the cerebral hematoma with minimum human error.

Also known as: ROSA

Intracerebral hemorrhage

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
• ICH volume ≥30 cc
• Surgery initiated within 48 hours of hospital admission

You may not qualify if:

• Pregnancy at the time of surgery
• Underlying vascular lesion defined as causative source of ICH
• Irreversible coagulopathy
• Profound neurological deficit defined as fixed/dilated pupils, bilateral extensor motor posturing
• Infratentorial or brainstem ICH
• Known life expectancy \<6 months

Sponsors & Collaborators

• Zimmer Biomet: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC Stroke Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijman C, Caron JL, Huang J, Camarata P, Mendelow AD, Gregson B, Janis S, Vespa P, Martin N, Awad I, Zuccarello M; MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol. 2016 Nov;15(12):1228-1237. doi: 10.1016/S1474-4422(16)30234-4. Epub 2016 Oct 11.

  PMID: 27751554 RESULT

• Vespa P, Hanley D, Betz J, Hoffer A, Engh J, Carter R, Nakaji P, Ogilvy C, Jallo J, Selman W, Bistran-Hall A, Lane K, McBee N, Saver J, Thompson RE, Martin N; ICES Investigators. ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke. 2016 Nov;47(11):2749-2755. doi: 10.1161/STROKEAHA.116.013837. Epub 2016 Oct 6.

  PMID: 27758940 RESULT

• Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.

  PMID: 23726393 RESULT

• Kim IS, Son BC, Lee SW, Sung JH, Hong JT. Comparison of frame-based and frameless stereotactic hematoma puncture and subsequent fibrinolytic therapy for the treatment of supratentorial deep seated spontaneous intracerebral hemorrhage. Minim Invasive Neurosurg. 2007 Apr;50(2):86-90. doi: 10.1055/s-2007-982503.

  PMID: 17674294 RESULT

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar Gonzalez, MD, DNP

  Zimmer Biomet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject enrolled serve as their own control to evaluate the effect of ROSA robotic-assisted intracerebral catheter placement.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 29, 2018
• Study Start: September 30, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)