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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
| University at Buffalo | OTHER |
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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.
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 or Artemis 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 or Artemis Device.
Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Management plus Apollo MIES | Experimental | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo MIES | Device | Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled Within 730 Days of First Enrollment | Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment | 730 days |
| Number of Participants With Available mRS Score | Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale - Mobility | 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:
| 180 days |
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Inclusion Criteria:
Exclusion Criteria:
Imaging
Coagulation Issues
Patient Factors
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| Name | Affiliation | Role |
|---|---|---|
| J Mocco, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| University of Louisville |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Management Plus Apollo MIES | Subjects received best medical management for ICH plus they received the MIES surgery and use of the Apollo System for clot evacuation. Apollo MIES: Subjects received best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System. Medical Management: Subjects received best medical management for intracranial hemorrhage |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2017 |
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|
| Medical Management | Other | Subjects will receive best medical management for intracranial hemorrhage |
|
|
| Stroke Impact Scale - ADLs | 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:
Stroke Impact Scale - ADL's full scale from 0-50, with higher score indicating better health outcomes. | 180 days |
| EQ-5D-5L | 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 Full scale from 0-25, with higher score indicating better health outcomes. | 180 days |
| Length of Hospital Stay | number of days of hospital stay | average of 14 days |
| Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3 | Number of participants with modified Rankin score (mRS) less than or equal to 3 to assess global disability assessed. The Modified Rankin Scale (mRS) The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
| 180 days |
| Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume | Predominantly or Only ICH: Number of participants who meet both criteria of reduction of reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan. Number of participants who meet both criteria of reduction of Hemorrhage volume as indication of surgical success. | 180 days |
| Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5 | Predominantly or Only IVH: number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 on day 7 CT scan. Number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 as indication of surgical success. | Day 7 |
| Number of Participants Who Died Within 90 Days of the Procedure | Rate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure. | 90 days |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| University of Buffalo | Buffalo | New York | 14260 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Prisma Health | Greenville | South Carolina | 29601 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medical Management Plus Apollo MIES | Subjects received best medical management for ICH plus they received the MIES surgery and use of the Apollo System for clot evacuation. Apollo MIES: Subjects received best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System. Medical Management: Subjects received best medical management for intracranial hemorrhage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled Within 730 Days of First Enrollment | Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment | Posted | Count of Participants | Participants | 730 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Available mRS Score | Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days | Posted | Count of Participants | Participants | 180 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale - Mobility | 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:
| Posted | Median | Inter-Quartile Range | score on a scale | 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale - ADLs | 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:
Stroke Impact Scale - ADL's full scale from 0-50, with higher score indicating better health outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | EQ-5D-5L | 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 Full scale from 0-25, with higher score indicating better health outcomes. | Posted | Median | Inter-Quartile Range | score on a scale | 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | number of days of hospital stay | Posted | Median | Inter-Quartile Range | days | average of 14 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3 | Number of participants with modified Rankin score (mRS) less than or equal to 3 to assess global disability assessed. The Modified Rankin Scale (mRS) The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
| Posted | Count of Participants | Participants | 180 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume | Predominantly or Only ICH: Number of participants who meet both criteria of reduction of reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan. Number of participants who meet both criteria of reduction of Hemorrhage volume as indication of surgical success. | Posted | Count of Participants | Participants | 180 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5 | Predominantly or Only IVH: number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 on day 7 CT scan. Number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 as indication of surgical success. | Posted | Count of Participants | Participants | Day 7 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died Within 90 Days of the Procedure | Rate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure. | Posted | Count of Participants | Participants | 90 days |
|
|
180 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medical Management Plus Apollo MIES | Subjects received best medical management for ICH plus they received the MIES surgery and use of the Apollo System for clot evacuation. Apollo MIES: Subjects received best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System. Medical Management: Subjects received best medical management for intracranial hemorrhage | 12 | 50 | 24 | 50 | 25 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental status | Psychiatric disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| ICH | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (unspecified) | Systematic Assessment |
| |
| Sepsis | Immune system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Intraoperative hemorrhage | Surgical and medical procedures | CTCAE (unspecified) | Systematic Assessment |
| |
| Postoperative hemorrhage | Surgical and medical procedures | CTCAE (unspecified) | Systematic Assessment |
| |
| Cerebral edema | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| GI bleed | Gastrointestinal disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| EVD Malfunction | Surgical and medical procedures | CTCAE (unspecified) | Systematic Assessment |
| |
| Ventriculitis | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Ventriculostomy Malfunction | Surgical and medical procedures | CTCAE (unspecified) | Systematic Assessment |
| |
| Increase lethargy/Encephalopathy | General disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Worsening of hemorrhage edema and midline shift | Blood and lymphatic system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| DVT | Blood and lymphatic system disorders | CTCAE (unspecified) | Systematic Assessment |
| |
| Neuro decline | Nervous system disorders | CTCAE (unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Altered mental status | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| UTI | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| ICH | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Sepsis | Immune system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Laryngeal edema | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Postoperative hemorrhage | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Desaturation | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Headache | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hiccups | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Delusions | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Broken Hip | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Right shoulder pain | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Left hip pain | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Amiodarone-induced hypothyroidism | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Bowel Perforation | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Tract hemorrhage | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Acute agitation | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypernatremia | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Weakness | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Dislodged PEG tube | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pneumothorax secondary to thoracentisis | Surgical and medical procedures | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Otomastoiditis | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Thromboembolic event | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha St. Elin | Icahn School of Medicine at Mount Sinai | (212) 241-1497 | samantha.stelin@mountsinai.org |
| Oct 27, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | Oct 27, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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