Clinical trials: Medical Device Complication
Segmentectomy
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy
According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation.
- Trial name
- NCT03192904
- Testing
- Energy Instruments, Stapling Device
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Ruijin Hospital
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
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
Post-operative Pain
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
- Trial name
- NCT01694199
- Testing
- Pulsed Radiofrequency Energy (PRFE), No Pulsed Radiofrequency Energy (PRFE)
- Where
- 3 sites in United States
- Volunteers
- 139 people
- Sponsor
- Regenesis Biomedical, Inc.
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
IV Catheter-Related Infection or Complication
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no…
- Trial name
- DIPPER (NCT04469218)
- Testing
- SafeBreak Vascular
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Lineus Medical
Airway Complication of Anesthesia
Observational Study of the LMA Protector
The investigators want to investigate the user friendliness, and performance of the LMA Protector. The principal research question is to assess the overall performance of the LMA Protector.
- Trial name
- ADEPT1 (NCT03664700)
- Testing
- LMA Protector
- Where
- 5 sites in United Kingdom
- Volunteers
- 112 people
- Sponsor
- Oxford University Hospitals NHS Trust
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Diabetes
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
- Trial name
- NCT02211495
- Testing
- GEKO device, Best Medical Therapy
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
Intubation Complication, Intubation;Difficult
Novel Airway Device to Aid Endotracheal Intubations
Pneumaglide is a device designed to facilitate intubation. Patients who are undergoing a surgical procedure under general anesthesia and will require placement of endotracheal tube will be screened and upon fulfilling the…
- Trial name
- NCT03340207
- Testing
- Pneumaglide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University at Buffalo
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
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Central Line Complication, Central Line Infection
Innovative Central Line Securement Device in the Pediatric Population
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a…
- Conditions
- Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis
- Trial name
- NCT04522778
- Testing
- Wearable Central Line Securement Device (Vest), Traditional Securement Dressing
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Ryan St. Pierre-Hetz
Vascular Access Complication
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01937195
- Testing
- AccuCath Intravenous Catheter System
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- C. R. Bard