Clinical trials: Automated Drug Delivery
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Diabetes, Diabetes Mellitus
French Prospective Multicentric Study in Real World
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1 Diabetes
- Trial name
- OPTIMAL-A (NCT07039942)
- Testing
- Omnipod 5
- Where
- 24 sites in France
- Volunteers
- 304 people
- Sponsor
- Insulet Corporation
Type 2 Diabetes Treated With Insulin
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting.
- Trial name
- NCT05238142
- Testing
- MiniMed™ 780G Insulin Pump system
- Where
- 31 sites in United States
- Volunteers
- 574 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes Mellitus, Diabetic Retinopathy
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images
AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software.
- Trial name
- NCT05857943
- Testing
- AEYE-DS Software
- Where
- 3 sites in United States
- Volunteers
- 363 people
- Sponsor
- AEYE Health Inc
Allergy
Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies
To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T.
- Trial name
- SPAT_AI (NCT05918354)
- Testing
- Skin Prick Automated Test
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 993 people
- Sponsor
- Hippocreates
Oocyte Cryopreservation
Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
This study will recruit 260 female recipients (and up to a maximum of 130 donors). This study is a sequel to the protocol CP-DV-000-GEN-003, entitled, "NON-INFERIORITY STUDY COMPARING OVERTURE SEMI-AUTOMATED VITRIFICATION SYSTEM…
- Trial name
- NCT06853418
- Testing
- Oocyte Cryopreservation
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Overture Life
Diabetic Retinopathy (DR)
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
- Trial name
- NCT07844317
- Testing
- SaMD intended for the detection of diabetic retinopathy in adults with diabetes., An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Digital Diagnostics, Inc.
Vertigo
AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
The eye movement records and vestibular pulse examinations obtained from patients with dizziness can provide characteristic parameters and features of eye movements and vestibular reflexes.
- Trial name
- NCT06115915
- Where
- Taiwan
- Volunteers
- 391 people
- Sponsor
- Neurobit Technologies Co., Ltd.
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Diabetic Retinopathy (DR)
Assessment of AI Program 'DRISTi' as a Screening Tool
A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes.
- Trial name
- NCT07222293
- Testing
- Fundus Image Grading
- Where
- 2 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Artelus AI
Diabetic Retinopathy
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults.
- Trial name
- NCT03078231
- Testing
- Color fundus photography, Mydriatic Agent
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Eyenuk, Inc.
Blood Sampling Procedure, Healthy
Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots
This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter.
- Trial name
- NCT04594577
- Testing
- Fluispotter
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Fluisense ApS
Stroke
Effect of Personalized Robotic Therapy
The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force…
- Trial name
- NCT02770300
- Testing
- Arm Light Exoskeleton Rehab Station (ALEx RS), Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized
- Where
- Switzerland
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Wearable Robotics srl.
NMIBC
Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors.
- Trial name
- LUMINA I (NCT07860398)
- Testing
- ATLAS system
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Optheras AS
Type 1 Diabetes Mellitus
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes.
- Trial name
- NCT03848767
- Testing
- AID System, Insulin Lispro
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eli Lilly and Company
Parkinson Disease
Automated Deep Brain Stimulation Programming Using Functional Mapping
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
- Trial name
- DBS-Expert (NCT02765282)
- Testing
- Algorithm based programming using Kinesia-based assessment
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Liver Cirrhosis, Refractory Ascites
ALFApump System Post Marketing Surveillance Registry
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
- Conditions
- Liver Cirrhosis, Refractory Ascites, Malignant Ascites
- Trial name
- 2011-AAR-004 (NCT01532427)
- Where
- 13 sites in Germany, Spain and 2 more
- Volunteers
- 100 people
- Sponsor
- Sequana Medical N.V.
Cataract
Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects
This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.
- Trial name
- NCT03824028
- Testing
- Clareon® IOL AutonoMe™ automated preloaded delivery system
- Where
- 3 sites in Japan
- Volunteers
- 384 people
- Sponsor
- Alcon Research
Type 1 Diabetes
Omnipod 5 System Compared to Pump Therapy
Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or…
- Trial name
- NCT05409131
- Testing
- Omnipod 5 System
- Where
- 14 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- Insulet Corporation
Mild Cognitive Impairment and Dementia
UK Validation of the Automated "AcceXible" Speech Analysis Software
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear.
- Trial name
- NCT05534958
- Testing
- Accexible
- Where
- United Kingdom
- Volunteers
- 221 people
- Sponsor
- Accexible