Clinical trials: medical devices
Prostate Cancer
Rectal Spacer for Prostate Cancer Radiation Image Guidance
The purpose of the study is to determine if a radiopaque hydrogel rectal spacer, SpaceOAR Vue®, can be used in place of fiducial markers when aligning patients for radiotherapy.
- Trial name
- NCT05650021
- Testing
- SpaceOAR Vue
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Milton S. Hershey Medical Center
Stem Cell Transplant, Adherence, Medication
BMT4me: Post-HSCT Medication Adherence mHealth App
This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase…
- Conditions
- Stem Cell Transplant, Adherence, Medication, Digital Health
- Trial name
- Bmt4me 2 (NCT05515497)
- Testing
- BMT4me 2.0 app
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Micah Skeens
Magnetic Resonance Imaging
Clinical Use of a New Neonatal MRI System
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal…
- Trial name
- NCT01801865
- Testing
- GE OPTIMA MR430s with HDX/GE Electronics
- Where
- United States
- Volunteers
- 657 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Tracheomalacia
Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed.
- Trial name
- NCT06028646
- Testing
- Dynamic Airway CT scan (DA-CT)
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- NYU Langone Health
Pain, Pain, Postoperative
Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
- Conditions
- Pain, Pain, Postoperative, Pain, Acute, Surgery
- Trial name
- NCT04943874
- Testing
- Technology Based Intervention Group 1, Technology Based Intervention Group 2
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Vanessa Olbrecht
Laryngeal Mask Airway in Children
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients.
- Trial name
- NCT01653795
- Testing
- LMA Unique: control device, LMA Supreme: comparison device
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Tracheal Intubation in Children
Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.
- Trial name
- NCT01535742
- Testing
- Ambu Aura-i size 1.5, air-Q ILA size 1.5, Ambu Aura-i size 2
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Diabetes Mellitus, Diabetes Mellitus, Type 1
Day and Night Closed-loop in Young People With Type 1 Diabetes
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases
- Trial name
- DAN05 (NCT02925299)
- Testing
- FlorenceM (US) and FlorenceX (UK), Insulin pump therapy
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 133 people
- Sponsor
- Jaeb Center for Health Research
Type 1 Diabetes, Hypoglycemia
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents
Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is…
- Conditions
- Type 1 Diabetes, Hypoglycemia, Hyperglycemia, Artificial Pancreas
- Trial name
- PHM3 (NCT02714972)
- Testing
- Hyperglycemia Minimization Algorithm
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Jaeb Center for Health Research
Epilepsy
Acute Recording of Stereotyped High-Frequency Oscillations
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates >=1kHz and deliver…
- Trial name
- NCT05439655
- Testing
- Brain Interchange System
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Pregnancy Related, Burnout, Professional
The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care.
- Conditions
- Pregnancy Related, Burnout, Professional, Wellness, Psychological
- Trial name
- NCT06014892
- Testing
- Snoo smart bassinet, Willow wearable breast pump, Maven Clinic on-demand perinatal consultation
- Where
- 7 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission
Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion
Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality.
- Conditions
- Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes, Chronic Myeloid Leukemia
- Trial name
- HAPLOTAB (NCT05236764)
- Testing
- CliniMACS
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine
Leukemia, Lymphoma
Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies
This is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T…
- Conditions
- Leukemia, Lymphoma, Myelodysplasia
- Trial name
- AB-CliniMACs (NCT02323867)
- Testing
- CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
Depression, Adolescent - Emotional Problem
Light Therapy for Depression in Adolescent Outpatients
The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question[s] it aimed to answer were: 1.
- Trial name
- NCT05823090
- Testing
- light box (Carex DayLight Classic Model)
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Respiratory Depression Neonatal
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a mobile health application called LIVEBORN; secondarily, to evaluate the relative effectiveness of real-time guidance vs debriefing.
- Trial name
- NCT05963516
- Testing
- LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation, NeoBeat: Heart Rate Meter for Newborn Resuscitation
- Where
- 4 sites in Democratic Republic of the Congo
- Volunteers
- 14,679 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Cerebral Palsy
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).
- Trial name
- NCT06455930
- Testing
- Stand-on ride-on power mobility device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of North Florida
Autism Spectrum Disorder, EEG With Periodic Abnormalities
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or…
- Conditions
- Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy, Neurodevelopmental Disorders
- Trial name
- tPBM (NCT06352372)
- Testing
- noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Richard Frye
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
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