Clinical trials: Closed Loop
Parkinson Disease
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
- Trial name
- CLOVER (NCT03037398)
- Testing
- Vercise Deep Brain Stimulation System
- Where
- 3 sites in Germany
- Volunteers
- 69 people
- Sponsor
- Boston Scientific Corporation
Diabetes Type 2
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.
- Trial name
- CLOSEAP+ (NCT04233229)
- Testing
- t:slim X2 with Control-IQ, home healthcare services, usual care for daily insulin treatment
- Where
- 10 sites in France
- Volunteers
- 43 people
- Sponsor
- Air Liquide Santé International
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Chronic Pain, Back Pain
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
- Conditions
- Chronic Pain, Back Pain, Pain
- Trial name
- EVOKE (NCT02924129)
- Testing
- Evoke Spinal Cord Stimulator (SCS) System
- Where
- 16 sites in United States
- Volunteers
- 134 people
- Sponsor
- Saluda Medical Americas, Inc.
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Social Anxiety
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
This study is a validation study to evaluate the acceptability, feasibility and impact of WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions), a mobile application employing a closed-loop technology in…
- Trial name
- WASABI (NCT03990870)
- Testing
- dCBGT + WASABI, dCBGT Only
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Posit Science Corporation
Type 1 Diabetes
Feasibility Studies of Personalized Closed Loop
This is a single arm study comprised of a series of feasibility studies.
- Trial name
- NCT04203823
- Testing
- Cloud-based Digital Twin and Meal Prediction algorithms
- Where
- 12 sites in United States
- Volunteers
- 126 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®
This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.
- Trial name
- NCT05325294
- Testing
- MiniMed 780G System
- Where
- 19 sites in United States
- Volunteers
- 244 people
- Sponsor
- Medtronic MiniMed, Inc.
Syncope, Syncope, Vasovagal
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing.
- Trial name
- BIO|Sync-HUTT (NCT06038708)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Biotronik SE & Co. KG
Syncope
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences.
- Trial name
- BIOSync CLS (NCT02324920)
- Testing
- DDD-CLS, ODO
- Where
- 24 sites in Canada, France and 4 more
- Volunteers
- 128 people
- Sponsor
- Biotronik SE & Co. KG
Wounds and Injuries, Respiratory Failure
FiO2 Closed Loop Control Ventilation
A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous…
- Trial name
- CLC (NCT02810080)
- Testing
- Closed Loop Control Ventilation, Manual Control Ventilation
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Zoll Medical Corporation
Type 1 Diabetes Mellitus
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
- Trial name
- ePID-03 (NCT00831389)
- Testing
- Closed Loop
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes type1
Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
SATURN study aims at evaluating Home Healthcare Provider (HHP) Management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions…
- Trial name
- SATURN (NCT04635280)
- Testing
- any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking
- Where
- 2 sites in France
- Volunteers
- 35 people
- Sponsor
- Air Liquide Santé International
Type 1 Diabetes Mellitus
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.
- Trial name
- NCT03959423
- Testing
- AHCL insulin pump system
- Where
- 17 sites in United States
- Volunteers
- 288 people
- Sponsor
- Medtronic MiniMed, Inc.
Overactive Bladder, Urinary Frequency
FREEOAB Study for Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
- Conditions
- Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
- Trial name
- NCT04547920
- Testing
- Wearable Bladder Modulation System
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Avation Medical, Inc.
Type 1 Diabetes
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin…
- Trial name
- NCT05403502
- Testing
- t:slim X2 insulin pump with Control-IQ technology 1.5
- Where
- 13 sites in United States
- Volunteers
- 183 people
- Sponsor
- Tandem Diabetes Care, Inc.
Type 1 Diabetes
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash…
- Trial name
- ADAPT (NCT04235504)
- Testing
- MDI, AHCL
- Where
- 14 sites in France, Germany and 1 more
- Volunteers
- 122 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes Mellitus, Type 2
Closed Loop Glucose Control in Patients With Type 2 Diabetes
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.
- Trial name
- NCT05386849
- Testing
- FUSION closed loop glucose control system
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ideal Medical Technologies
Low Back Pain, Leg Pain
Medtronic Closed-Loop Spinal Cord Stimulation System
The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.
- Conditions
- Low Back Pain, Leg Pain, Upper Limb Pain
- Trial name
- NCT05177354
- Testing
- Inceptiv
- Where
- 7 sites in Australia
- Volunteers
- 94 people
- Sponsor
- MedtronicNeuro
Diabetes Mellitus, Type 1
MiniMed™ 670G System China Study for Type I Diabetic
The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China.
- Trial name
- NCT04663295
- Testing
- MiniMed™ 670G system
- Where
- 4 sites in China
- Volunteers
- 74 people
- Sponsor
- Medtronic MiniMed, Inc.