## Protocol Section
### Identification Module
**NCT ID:** NCT03865979

**Brief Title:** AI ENRICH - AI Detection of ICH

**Official Title:** Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial

#### Organization Study ID Info
**ID:** VIZ-ICH-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Viz.ai, Inc.
### Status Module
#### Completion Date
**Date:** 2022-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2022-04-27

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-26

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-01-23

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2019-03-07
**Type:** ACTUAL
**Study First Submit Date:** 2019-03-04
**Study First Submit QC Date:** 2019-03-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Nico Corporation

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Viz.ai, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.

**Detailed Description:** This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.

### Conditions Module

**Conditions:**

- Intracerebral Hemorrhage

**Keywords:**

- Artificial Intelligence

- ICH

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 5000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID.

Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial

**Intervention Names:**

- Device: Viz RECRUIT

**Label:** Intervention Arm

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation

**Label:** Control Arm

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Arm

**Description:** Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB

**Name:** Viz RECRUIT

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.

**Measure:** Performance

**Time Frame:** Enrollment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects with stroke symptoms who undergo CT brain imaging.

Exclusion Criteria:

* Subjects with poor or incomplete CT brain imaging.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**Facility:** UAMS Medical Center

**State:** Arkansas

**Zip:** 72205

**Location 2:**

**City:** Evanston

**Country:** United States

**Facility:** Northshore University Health System

**State:** Illinois

**Zip:** 60201

**Location 3:**

**City:** Camden

**Country:** United States

**Facility:** Cooper University Hospital

**State:** New Jersey

**Zip:** 08103

**Location 4:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467

**Location 5:**

**City:** Buffalo

**Country:** United States

**Facility:** SUNY Buffalo

**State:** New York

**Zip:** 14203

**Location 6:**

**City:** Danville

**Country:** United States

**Facility:** Geisinger Medical Center

**State:** Pennsylvania

**Zip:** 17822

#### Overall Officials

**Official 1:**

**Affiliation:** The Cooper Health System

**Name:** Brian T Jankowitz, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5792

- Name: Cerebral Hemorrhage

- Relevance: HIGH

- As Found: Intracerebral Hemorrhage

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002543

- Term: Cerebral Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Misc Info Module

- Version Holder: 2024-05-24
