Clinical trials: Medical Device Complication
Intravenous Access, Medical Device
Safe-Infusion Study
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or…
- Trial name
- NCT06727240
- Testing
- Intervention
- Where
- 2 sites in Portugal, Spain
- Volunteers
- 548 people
- Sponsor
- Interlinked AB
Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis
Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
- Trial name
- Vagitab (NCT06725888)
- Testing
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
- Where
- Romania
- Volunteers
- 30 people
- Sponsor
- S.I.I.T. Srl
Device Induced Injury, Necrosis, Pressure
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized…
- Conditions
- Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion, Airway Morbidity
- Trial name
- NCT01367678
- Testing
- Laryngeal Mask Airway Supreme, i-Gel extraglottic airway device
- Where
- 2 sites in Austria, Switzerland
- Volunteers
- 30 people
- Sponsor
- Schulthess Klinik
Local Anaesthetic Complication, Pain
Kinetic Anesthesia Device Study
Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine…
- Trial name
- NCT03344510
- Testing
- Kinetic Anesthesia Device, Control
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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
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
Apnea of Prematurity, Intermittent Hypoxia
Pilot Study to Evaluate Doses of Mechanical Stimulus on the Effectiveness of Preterm Breathing
The goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer: if there is a dose of dorsal mechanical stimuli that improves the basal respiration.
- Trial name
- NCT06639581
- Testing
- 20 per minute stimulus, 30 per minute stimulus, 40 per minute stimulus
- Where
- Chile
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Chronic Kidney Diseases, Diabetes
KidneYou - Innovative Digital Therapy
The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness…
- Conditions
- Chronic Kidney Diseases, Diabetes, Arterial Hypertension, Chronic Glomerulonephritis
- Trial name
- NCT05286632
- Testing
- KidneYou APP
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Advice Pharma Group srl
IUD Insertion Complication
Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section
The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.
- Trial name
- NCT03587077
- Testing
- Misoprostol, isosorbide mononitrate
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Assiut University
Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
Remove LPS Registry
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have…
- Trial name
- NCT05260099
- Testing
- LPS Adsorber
- Sponsor
- Alteco Medical AB
Tracheostomy, Mechanical Ventilation Complication
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
Although tracheostomy is a common technique in Intensive Care Units (ICU), its complications can be frequent (between 5% to 40%).
- Trial name
- DYNAtraq (NCT04668742)
- Testing
- DYNAtraq
- Where
- Colombia
- Volunteers
- 74 people
- Sponsor
- Fundación Cardiovascular de Colombia
Bacterial Vaginosis | Vaginal | Microbiology
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
- Trial name
- NCT04489290
- Testing
- D005 Vaginal Mousse
- Where
- 9 sites in Sweden, United Kingdom
- Volunteers
- 83 people
- Sponsor
- PepTonic Medical AB
Arrhythmias, Cardiac, Venous Puncture
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable…
- Conditions
- Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication
- Trial name
- ZEROFLUOROAXI (NCT05101720)
- Testing
- Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access
- Where
- Italy
- Volunteers
- 280 people
- Sponsor
- University Hospital of Ferrara
Post-Op Complication, Skin Flap Necrosis
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. ViOptix probes will be secured to the arm and hand.
- Trial name
- NCT05592145
- Testing
- ViOptix
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Endoscopic Full Thickness Resection (EFTR), Residual /Recurrent Colorectal Lesion
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD).
- Conditions
- Endoscopic Full Thickness Resection (EFTR), Residual /Recurrent Colorectal Lesion, Full-thickness Resection Device (FTRD), Colorectal Adenoma
- Trial name
- NCT05913453
- Where
- Italy
- Volunteers
- 77 people
- Sponsor
- Azienda Unità Sanitaria Locale della Romagna
Ankle Fracture - Lateral Malleolus, Post-Op Complication
Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures
- Trial name
- NCT04168307
- Testing
- Ankle trainer device, Conventional physiotherapy
- Volunteers
- 113 people
- Sponsor
- Oslo University Hospital
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Trial name
- NCT05782296
- Testing
- TrueLabor
- Where
- 3 sites in United States, Israel
- Volunteers
- 80 people
- Sponsor
- OB-Tools Ltd.
Opioid Use, Unspecified, Remifentanil
Anesthesia for Vascular Access Devices
Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored…
- Conditions
- Opioid Use, Unspecified, Remifentanil, Sedation Complication, Analgesia
- Trial name
- NCT04749069
- Testing
- Comparison of pain intensity rating scale
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 107 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IUCD Complication
Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean…
- Trial name
- NCT04499989
- Testing
- INH
- Where
- Egypt
- Volunteers
- 220 people
- Sponsor
- Aswan University Hospital
IUCD Complication
Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion
To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in…
- Trial name
- NCT04505943
- Testing
- Isonicotinic Acid Hydrazide, dinoprostine, misoprostol
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Aswan University Hospital