Intracerebral HematomaNCT03414307
Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation
A study testing Intracerebral catheter placement and Robot-assisted intracerebral catheter in people with Intracerebral Hematoma, run by Zimmer Biomet at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hematoma
- What is being tested?
- Intracerebral catheter placement and Robot-assisted intracerebral catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
- ICH volume ≥30 cc
- Surgery initiated within 48 hours of hospital admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Stroke Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation
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.
Read the detailed description
The introduction of the ROSA stereotactic robot offers an image guided stereotactic approach with greater precision and accuracy than traditional frame-based and frameless methods. While the ROSA has never been used for the placement of intra-hemorrhage catheters, prior applications such as brain biopsies and abscess drainage represent similar surgical procedures which require the same planning, precision, and surgical technique. At the very least, ROSA offers an accurate image guided approach to deep lesions that should be comparable to competitive image guided platforms. At best, ROSA offers superior trajectory planning software, greater ease in planning multiple trajectories to large, irregular clots, and the potential for robot aided navigation into and out of the hematoma which is the greatest source of human error in these cases. For instance, the procedure often requires advancement of a larger aspiration catheter, slow aspiration as the catheter is withdrawn, and then re-advancement of a smaller catheter into the hematoma, which is left in place. The ability to advance and remove catheters in a fixed trajectory with robotic assistance may represent the greatest advantage of ROSA.
- Conditions
- Intracerebral Hematoma
- Being tested
- Intracerebral catheter placement, Robot-assisted intracerebral catheter
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracerebral catheter placementProcedure or surgery
Also called Stereotactic catheter placement
Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage
Robot-assisted intracerebral catheterDevice
Also called ROSA
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral hemorrhage | Experimental | Patients with ICH meeting inclusion/exclusion criteria undergo ROSA stereotactic robot-assisted intracerebral catheter placement to evacuate intracerebral or intracranial hemorrhage Receives: Procedure: Intracerebral catheter placement; Device: Robot-assisted intracerebral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma volume reduction
Percentage of hematoma evacuation identified by CT scan
Measured: Day 1 to Day 4 post operative
Secondary outcomes (2)
Linear measurement of accuracy
Accuracy of catheter placement is assessed by comparing planned stereotactic trajectories to actual location of the intracerebral catheter. Measure of linear displacement is given in millimeters.
Measured: Day 0
Functional Outcomes measured by modified Rankin Scale (mRS) for neurologic disabilities
mRS evaluates in a scale 0-6 the degree of disability in patients who have suffered a cerebral stroke or hemorrhage.
Measured: Baseline, 3-month, 6-month and 1-year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start30 Sep 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: COVID 19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HematomaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subject enrolled serve as their own control to evaluate the effect of ROSA robotic-assisted intracerebral catheter placement.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- Oscar Gonzalez, MD, DNP, Study chair, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414307
- Sponsor's protocol ID
- 0717-1
- Status last verified
- Jul 2021
- First submitted
- 16 Jan 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27751554Vespa 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.
PubMed 27758940Mendelow 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.
PubMed 23726393Kim 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.
PubMed 17674294
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation
- ClinicalTrials.gov ID
- NCT03414307
- Acronym / sponsor ID
- 0717-1
- Conditions
- Intracerebral Hematoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19 Pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The introduction of the ROSA stereotactic robot offers an image guided stereotactic approach with greater precision and accuracy than traditional frame-based and frameless methods. While the ROSA has never been used for the placement of intra-hemorrhage catheters, prior applications such as brain biopsies and abscess drainage represent similar surgical procedures which require the same planning, precision, and surgical technique. At the very least, ROSA offers an accurate image guided approach to deep lesions that should be comparable to competitive image guided platforms. At best, ROSA offers superior trajectory planning software, greater ease in planning multiple trajectories to large, irregular clots, and the potential for robot aided navigation into and out of the hematoma which is the greatest source of human error in these cases. For instance, the procedure often requires advancement of a larger aspiration catheter, slow aspiration as the catheter is withdrawn, and then re-advancement of a smaller catheter into the hematoma, which is left in place. The ability to advance and remove catheters in a fixed trajectory with robotic assistance may represent the greatest advantage of ROSA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subject enrolled serve as their own control to evaluate the effect of ROSA robotic-assisted intracerebral catheter placement.
| Arm | Type | Receives |
|---|---|---|
| Intracerebral hemorrhage | Experimental | Procedure: Intracerebral catheter placement, Device: Robot-assisted intracerebral catheterPatients with ICH meeting inclusion/exclusion criteria undergo ROSA stereotactic robot-assisted intracerebral catheter placement to evacuate intracerebral or intracranial hemorrhage |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-85
- Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
- ICH volume ≥30 cc
- Surgery initiated within 48 hours of hospital admission
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracerebral catheter placementAlso: Stereotactic catheter placementImage guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage | Procedure or surgery | Intracerebral hemorrhage |
| Robot-assisted intracerebral catheterAlso: ROSAROSA 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. | Device | Intracerebral hemorrhage |
Primary outcome
Hematoma volume reduction
Time frame: Day 1 to Day 4 post operative
Percentage of hematoma evacuation identified by CT scan
2 secondary outcomes
Linear measurement of accuracy
Time frame: Day 0
Functional Outcomes measured by modified Rankin Scale (mRS) for neurologic disabilities
Time frame: Baseline, 3-month, 6-month and 1-year post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Results publication: PubMed 27751554Hanley 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.
- Results publication: PubMed 27758940Vespa 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.
- Results publication: PubMed 23726393Mendelow 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.
- Results publication: PubMed 17674294Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Gonzalez, MD, DNP study chair
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracerebral catheter placement and Robot-assisted intracerebral catheter in people with Intracerebral Hematoma, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma volume reduction (time frame: Day 1 to Day 4 post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414307, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.