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INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
NA trial testing Apollo Device in Intracranial Hemorrhage in 38 participants. Completed in 16 November 2022.
| Lead sponsor | J. Mocco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 14 October 2016 |
| Primary completion | 16 November 2022 |
| Estimated completion | 16 November 2022 |
| Sites | 7 locations across United States |
J. Mocco
22 and older, any sex, with Intracranial Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS). 180-day global disability assessed via the modified Rankin score (mRS), categorized as either mRS ≤ 3 or mRS \> 3
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 20 |
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as reduction to \< 15 cc total volume AND \>60% reduction in hemorrhage volume on immediate post-treatment CT scan
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 27 |
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as Intraventricular hemorrhage (IVH): mGraeb score of \< 5 on day 7 CT scan
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 1 |
0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 1 | |
| Patients With Brain Hemorrhage | 2 | |
| Patients With Brain Hemorrhage | 1 | |
| Patients With Brain Hemorrhage | 6 |
0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 2 | |
| Patients With Brain Hemorrhage | 2 | |
| Patients With Brain Hemorrhage | 5 | |
| Patients With Brain Hemorrhage | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 14.5 | 9.3 – 24.0 |
Number of participants requiring Ventriculoperitoneal Shunt (VPS)
| Group | Value | 95% CI |
|---|---|---|
| Patients With Brain Hemorrhage | 3 |
Time frame: up to 6 months post-procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Patients With Brain Hemorr… |
|---|---|---|
| Stroke | Nervous system disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Deep venous thrombosis | Vascular disorders | — |
| Pulmonary embolism | Vascular disorders | — |
| Acute hemorrhage | Nervous system disorders | — |
| Acute inflammatory demyelinating polyneuropathy | Nervous system disorders | — |
| Aspiration pneumonia/fever | Infections and infestations | — |
| C. diff infection | Infections and infestations | — |
| Cranioplasty infection | Infections and infestations | — |
| Facial fractures | Injury, poisoning and procedural complications | — |
| Headache | Nervous system disorders | — |
| Hypotension | Vascular disorders | — |
| Deep seated right brain lesion due to brain abscess | Infections and infestations | — |
| Myocardial infarction | Cardiac disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Pneumonia | Infections and infestations | — |
| Polycythemia vera | Blood and lymphatic system disorders | — |
| R frontal ICH | Nervous system disorders | — |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | — |
| Sepsis secondary to aspiration | Infections and infestations | — |
| Syncope | Nervous system disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Wound infection | Infections and infestations | — |
| Reaction | System | Patients With Brain Hemorr… |
|---|---|---|
| Fever | General disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Hypernatremia | Investigations | — |
| Urinary tract infection | Infections and infestations | — |
| Hypertension/hypertensive episode | Vascular disorders | — |
| Seizure | Nervous system disorders | — |
| Stroke | Nervous system disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Acute encephalopathy | Nervous system disorders | — |
| Ankle fracture | Injury, poisoning and procedural complications | — |
| Aspiration pneumonia | Infections and infestations | — |
| Back rash | Immune system disorders | — |
| Chest pain - cardiac | Cardiac disorders | — |
| Craniotomy site oozing | Injury, poisoning and procedural complications | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hematoma | Vascular disorders | — |
| Hydrocephalus | Nervous system disorders | — |
| Hyperchloremia | Investigations | — |
| Hypomagnesemia | Investigations | — |
| Hypopotassemia | Investigations | — |
| Intraventricular hemorrhage | Nervous system disorders | — |
| L great toe abscess | Infections and infestations | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Pulmonary edema | Reproductive system and breast disorders | — |
| Pulmonary emboli | Vascular disorders | — |
| Suicide attempt | Psychiatric disorders | — |
| Transaminitis | Investigations | — |
| Urinary retention | Renal and urinary disorders | — |
| Worsening of chronic kidney disease | Renal and urinary disorders | — |
Most-reported serious reactions: Stroke, Abdominal pain, Acute respiratory failure, Deep venous thrombosis, Pulmonary embolism, Acute hemorrhage, Acute inflammatory demyelinating polyneuropathy, Aspiration pneumonia/fever.
Data from ClinicalTrials.gov NCT02661672 adverse events section.
Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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