Search clinical trials for: Software as medical device

Total 477967 results

INFINITT Healthcare
Korea Medical Device Development Fund

Recruiting

Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening: A Multicenter RCT (AIGatekeeper)

Coronary Artery Disease | Diagnosis

Korea, Republic of
Volta Medical
Fortrea

Recruiting

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation (COMRADE-AI)

Atrial Fibrillation | Arrhythmias, Cardiac | Atrial Arrhythmia

France
Click Therapeutics, Inc.
Boehringer Ingelheim

Recruiting

An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia

Schizophrenia | Negative Symptoms in Schizophrenia

United States
HAII corp.ltd

Recruiting

Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

Generalized Anxiety Disorder

Korea, Republic of
Click Therapeutics, Inc.
Boehringer Ingelheim

Recruiting

Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE)

Schizophrenia

United States
Cvaid Medical

Recruiting

The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

Stroke | Stroke, Ischemic | Stroke, Acute | Stroke Hemorrhagic | Stroke, Cardiovascular

Israel
Sierra Neurovision
CEISO; Institut des Sciences de la Vision

Not yet recruiting

Performance and Safety Evaluation of the S360 Medical Device Software. (ArgoS360)

Binocular Vision Disorder | Binocular Eye Movement Disorder | Ocular Motion; Disorder

France
Assistance Publique - Hôpitaux de Paris
Evolucare Technologies; InES - Innovation Electronic Software

Not yet recruiting

Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device (SMARTANGEL)

Medical Device

France
Advice Pharma Group srl

Recruiting

KidneYou - Innovative Digital Therapy

Diabetes | Chronic Kidney Diseases | Tuberous Sclerosis | Albuminuria | Treatment Adherence | Arterial Hypertension | Treatment Adherence and Compliance | Nephronophthisis | Polycystic Kidney | Chronic Glomerulonephritis | Cystic Kidney Diseases | Cortical Cystic Disease | Cystic Diseases

Italy
Aristotle University Of Thessaloniki

Recruiting

TMS Combined With EEG/EMG as a Biomarker Predicting Antiepileptic Drug Response (BIOEPI)

Focal Epilepsy

Greece
Radboud University Medical Center
University Medical Center Groningen; European Union; Instituto de Saude Publica... and other collaborators

Recruiting

Tuberculosis Screening in Paraguayan Prisons (Prinose)

Radiography | Volatile Organic Compounds

Paraguay
Docbot, Inc.

Recruiting

To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age (AIDA)

Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal SSA

United States
S-Alpha Therapeutics, Inc.

Active, not recruiting

Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders

Posttraumatic Stress Disorder

Korea, Republic of
Click Therapeutics, Inc.

Completed

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine (ReMMi-D)

Migraine | Headache | Headache, Migraine | Episodic Migraine

United States
Click Therapeutics, Inc.

Active, not recruiting

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

Migraine | Headache | Headache, Migraine | Episodic Migraine

United States
Click Therapeutics, Inc.

Completed

An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer

Multiple Sclerosis | Breast Cancer | Lung Cancer

United States
S-Alpha Therapeutics, Inc.

Completed

Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia

Children Myopia

Korea, Republic of
[Redacted]
Golden State Dermatology

Withheld

[Trial of device that is not approved or cleared by the U.S. FDA]

Skin Cancer | Skin Lesion | Skin Melanoma | Skin Cancer, Non-Melanoma | Skin Cancers - Squamous Cell Carcinoma | Skin Cancers - Basal Cell Carcinoma

United States
Medhub Ltd.

Completed

Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device (AutocathFFR)

Stable Angina | Unstable Angina | NSTEMI

Israel
Click Therapeutics, Inc.
Boehringer Ingelheim

Completed

A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia

Schizophrenia

United States
Advice Pharma Group srl

Active, not recruiting

DEMETRA - ADVICE-002-2022

Obesity | Nutrition Disorders | Body Weight | Weight Loss | Dietary Habits | Overweight and Obesity | Health Behavior | Diet, Healthy | Diet Habit | Life Style | Nutrition, Healthy | Behavioral Disorder

Italy
Omni C&S

Enrolling by invitation

Study of Virtual Reality-based Medical Device for Patients With Depressive Disorder

Depressive Disorder | Major Depressive Disorder | Depressive Episode

Korea, Republic of
Pragmatech AI Solutions
NAMSA; Grupo Hospital de Madrid

Completed

Evaluation of the Artificial Intelligence-based Prescription Support Software iAST® for the Choice of Empirical and Semi-targeted Antibiotic Treatment (EVIAST)

Bacterial Infections

Spain
Volta Medical

Completed

AutoMatic disPERsion Tagging Function Preliminary Evaluation (AMPERE)

Atrial Fibrillation | Atrial Tachycardia | Atrial Arrhythmia

France
Neurobit Technologies Co., Ltd.
Taipei Medical University; Buddhist Tzu Chi Medical Foundation

Completed

AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage

Vertigo

Taiwan
Click Therapeutics, Inc.

Completed

7-week Study With CT-155 in People With Schizophrenia

Schizophrenia

United States
University of Maryland, Baltimore
Baltimore VA Medical Center

Withdrawn

CGM/Clarity Use, Glycemic Control and Clinical Outcomes

Hyperglycemia | Diabetes Mellitus | Hypoglycemia

United States
University Hospital, Strasbourg, France

Completed

Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication (MORPHEE 2)

Post-operative Situation

France
Centre hospitalier de l'Université de Montréal...
Boehringer Ingelheim; Greybox

Active, not recruiting

Continuum: Digital Health to Manage Heart Failure Outpatients

Heart Failure | Chronic Heart Failure

Canada
Advice Pharma Group srl

Completed

MargheRITA (Remote Intelligence for Therapeutic Adherence) (MargheRITA)

Acute Myeloid Leukemia | Multiple Myeloma | Hodgkin Lymphoma | Amyloidosis | Chronic Lymphocytic Leukemia | Chronic Myeloid Leukemia | Treatment Adherence | Myelodysplasia | Lymphocytic Lymphoma | Treatment Adherence and Compliance | T Cell Non-Hodgkin Lymphoma | B-cell Non Hodgkin Lymphoma | Solitary Plasmacytoma and other conditions

Italy
Blue Note Therapeutics

Terminated

Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment

Anatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8

United States
Tilak Healthcare

Completed

Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002) (TIL002)

Visual Impairment

France
Adhera Health, Inc.
Maastricht University Medical Center; Hospital Universitario Reina Sofia de... and other collaborators

Completed

CARINAE for Stress Relief in Perioperative Care (CARINAE)

Kidney Cancer | Scoliosis | Prostate Cancer | Bladder Cancer | Knee Replacement | Orthognathic Surgery | Coronary Artery Bypass Surgery | Hip Replacement | Psychological Stress | Cardiopulmonary Bypass Surgery | Cardiac Valve Replacement

Netherlands, Spain, Italy
AudibleHealth AI, Inc.
Sunrise Research Institute; Analytical Solutions Group, Inc.; Kelley Medical... and other collaborators

Completed

Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation

Coronavirus Disease 2019 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19 | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease

United States
AudibleHealth AI, Inc.
University of South Florida; Analytical Solutions Group, Inc.; R. P. Chiacchierini... and other collaborators

Completed

Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness

COVID19

United States
metaMe Health

Completed

Efficacy and Safety of IBS Digital Behavioral Treatment (EASITx)

Irritable Bowel Syndrome

United States
Iterative Scopes, Inc
University of Minnesota

Completed

Computer Aided Detection of Polyps in Colonoscopy

Colorectal Polyp

United States
Adrien Schwitzguebel

Withdrawn

Diagnosis Assessment With Diaana #3

Patient Engagement | Decision Making | General Practitioners | Computer-assisted

Switzerland
Assistance Publique - Hôpitaux de Paris
Evolucare Technologies; InES - Innovation Electronic Software

Unknown

Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD) (SMART-METRO)

Medical Device

France
Adrien Schwitzguebel

Completed

DD Assessment With Diaana #2 (DiaanaRCT#2)

Patient Engagement | Decision Making | General Practitioners | Computer-assisted

Switzerland
Morley Medical
Morley Research Consortium

Unknown

A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms

Sepsis
Hospital San Carlos, Madrid

Unknown

Prediction Medical Device for Rheumatoid Arthritis (PREDIRA) (PREDIRA)

Arthritis, Rheumatoid

Spain
Providence Little Company of Mary-Torrance
Viz.ai, Inc.

Unknown

Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT) (ALERT)

Stroke Workflow and Clinical Outcome Parameters

United States
Philips Respironics

Terminated

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device (SV3-ST)

Sleep Disordered Breathing

United States
University of Edinburgh
Medical Research Council; NHS Lothian; NHS Greater Glasgow and Clyde; University... and other collaborators

Completed

Validating Studies to Assess the Diagnostic Accuracy of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium

Delirium | Dementia

United Kingdom
Two Pi Signalprocessing Applications GmbH

Completed

Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning (SelfFit)

Mild to Moderate Sensorineural Hearing Loss

Netherlands
Xuanwu Hospital, Beijing
Beijing Tiantan Hospital; Qilu Hospital of Shandong University; The Affiliated... and other collaborators

Recruiting

Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy

Treatment

China
Columbia University

Recruiting

VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction

Pain, Postoperative | Opioid Use | ACL | Vibration; Exposure | Cryotherapy Effect

United States
Fluidx Medical Technology, Inc.
Bright Research Partners

Not yet recruiting

Evaluation of a Simple-Prep Controlled Embolic (GPX)

Renal Cell Carcinoma | Embolism | Bone Tumor | Portal Vein Embolism | Renal Angiomyolipoma | Vascular Tumor
KOKO Medical Inc.

Not yet recruiting

Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage (SERENE)

Postpartum Hemorrhage | Hemorrhage, Postpartum | Immediate Postpartum Hemorrhage

United States

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