Clinical trials: Medical Device Complication, open to volunteers
Vascular Access, Vascular Access Complication
Novel Medical Device for Pharmacological Therapy
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient.
- Conditions
- Vascular Access, Vascular Access Complication, Vascular Access Complications, Catheter Malfunction
- Trial name
- Sechold (NCT06938750)
- Testing
- SECHOLD DEVICE
- Where
- Spain
- Volunteers
- 262 people
- Sponsor
- Fundacion Miguel Servet
Oncology, Interventional Radiology
Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy
This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue…
- Conditions
- Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma
- Trial name
- NCT07046832
- Testing
- Augmented Reality Guided Biopsy, Ultrasound Guided Biopsy
- Where
- 3 sites in United States
- Volunteers
- 104 people
- Sponsor
- MediView XR, Inc.
Implant Complication, Contraceptive Device; Complications
Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy.
- Trial name
- ABLES (NCT06355713)
- Testing
- Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample, urine collection
- Where
- 10 sites in France
- Volunteers
- 444 people
- Sponsor
- Hospices Civils de Lyon
Opioid Use, Pain, Postoperative
Opioid Dispenser for Microdiscectomy/Laminectomy
The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use…
- Conditions
- Opioid Use, Pain, Postoperative, Medical Device, Laminectomy
- Trial name
- NCT06358040
- Testing
- Opioid-Dispensing Device, App, Standard Opioid Pill Bottle
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hospital for Special Surgery, New York
Kidney Stones, Urolithiasis
DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Trial name
- DISON I (NCT07712861)
- Testing
- RIRS with Investigational Device
- Where
- 5 sites in Argentina, Canada and 3 more
- Volunteers
- 75 people
- Sponsor
- Ventaris Surgical Incorporated
Treatment Outcome, Vascular Access
Reduction of Complications Associated With PICC Management
The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care…
- Conditions
- Treatment Outcome, Vascular Access, Vascular Access Device, Vascular Access Complication
- Trial name
- PICC managemen (NCT06944327)
- Testing
- MANAGEMENT CARE, traditional care
- Volunteers
- 460 people
- Sponsor
- Fundacion Miguel Servet
Urinary Incontinence
Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of…
- Trial name
- PRIME (NCT06285292)
- Testing
- EMY
- Where
- France
- Volunteers
- 138 people
- Sponsor
- Nantes University Hospital
Post-Op Complication
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post…
- Trial name
- LENIENT (NCT04915261)
- Testing
- Lenient Arm Restriction, Strict Arm Restriction
- Where
- Canada
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Ottawa Heart Institute Research Corporation
Women With Suspected or Confirmed Gynecological Disease
DOvEEgene Fleur: New Uterine Sampling Tool
This study is related to a previous study from the same group which started in 2014 (NTC02288676, McGill REB A08-M79-13B, MUHC REB 2020-5945) to develop a clinically implementable screening test -DovEEgene: developing and…
- Trial name
- NCT04258449
- Testing
- DOvEEgene Fleur Sampling
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- McGill University
Cancer of the Breast, Cancer of Stomach
Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV)
This is performed under Vocorder project that is Co-Funded by the European Union. (Grant Agreement 101115442 VOCORDER HORIZON EIC-2022-PATHFINDERCHALLENGE-01).
- Conditions
- Cancer of the Breast, Cancer of Stomach, Colon Cancer, Lung Cancers
- Trial name
- VCV (NCT06711939)
- Where
- Greece
- Volunteers
- 515 people, healthy volunteers welcome
- Sponsor
- Mitera Hospital
Kidney Failure, Chronic, Kidney Transplantation
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Cold ischemia time, the period during which a donated kidney is kept cold outside the body between its removal from the donor and its transplantation into the recipient, is one of the main modifiable factors influencing how…
- Conditions
- Kidney Failure, Chronic, Kidney Transplantation, Delayed Graft Function, Cold Ischemia
- Trial name
- RAfALREIN (NCT07851571)
- Testing
- Kidney graft transport by autonomous unmanned aircraft (drone) between the procurement and transplantation centres
- Volunteers
- 5 people
- Sponsor
- Nantes University Hospital
Diabetic Retinopathy
Validation of the Artificial Intelligence Subsystem of the DDART Medical Device for the Automated Detection of Lesions Compatible With Diabetic Retinopathy in a Random Sample of Retinal Fundus Photographs
To validate the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with diabetic retinopathy in a random sample of retinal fundus photographs.
- Trial name
- NCT07758582
- Testing
- Color retinal fundus photograph
- Where
- Greece
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Democritus University of Thrace
Premature Infant
Calmer Brains in Very Preterm Infants
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development.
- Trial name
- NCT07262385
- Testing
- Calmer
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Post-Op Complication
Perioperative Smart Device Monitoring to Predict Complications
This is a prospective, single-center, observational study designed to to quantify complications following non cardiac intermediate and high-risk surgery, and to identify digital biomarkers (collected pre, and post-operatively by…
- Trial name
- PreSmart (NCT06156033)
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Hypertension, Pre-eclampsia
Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in pregnancy and pre-eclampsia
- Trial name
- WIHYP-PW (NCT07595016)
- Testing
- Blood pressure measurement
- Where
- Armenia
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Withings
Medical Device-Related Pressure Injury, Prematurity
Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in…
- Trial name
- NIV-MDRPI (NCT07521410)
- Testing
- Binasal Prong, Nasal Cannula, Nasal Mask
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Istanbul University - Cerrahpasa
Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction
Radio-frequency (RF) Bladder Monitor
The goal of this pilot feasibility study is to evaluate a wearable microwave (MW)-based bladder monitoring system in adult volunteers and those with spinal cord injury (SCI) who use self-catheterization for bladder management.
- Conditions
- Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction, Neurogenic Bladder (NB)
- Trial name
- NCT07639541
- Testing
- Wearable microwave Bladder Monitoring System
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Postoperative Complication, Respiratory Complications
Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery: a Study for the Early Identification of Complications in the Surgical Ward Following Surgery in Patients Not Eligible for Intensive Care Admission.
This study aims to evaluate whether continuous vital sign monitoring with wearable devices can help detect postoperative complications in surgical ward earlier than standard hospital monitoring.
- Conditions
- Postoperative Complication, Respiratory Complications, Cardiac Complications
- Trial name
- RECOVER (NCT07729891)
- Testing
- Continuous vital sign monitoring with Portrait Mobile in surgical ward
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
Treatment (ProudMe), Vascular Access
Reduction of Complications Associated With Extraluminal PICC Management.
The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care…
- Conditions
- Treatment (ProudMe), Vascular Access, Vascular Access Complication, Nurse
- Trial name
- QualityPICC2 (NCT07802314)
- Testing
- G2:PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days, G3: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days
- Volunteers
- 240 people
- Sponsor
- Fundacion Miguel Servet
High-risk Pregnancy, Pregnancy
AI-Powered CURAᵀᴹ Application for Identifying At-Risk Pregnancies in Obstetric Management
It is important to identify high pregnancies early through screening so that appropriate care and intervention may be instituted.
- Conditions
- High-risk Pregnancy, Pregnancy, Antenatal Health
- Trial name
- CURAte (NCT06974188)
- Testing
- AI-risk Stratification
- Where
- Singapore
- Volunteers
- 1,700 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore