Clinical trials: Implant Complication
Pregnancy, Fertility
Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome
PIF: biomarker of successful implantation To overcome the poor reproductive potential of embryos generated during in vitro fertilization cycles and the lack of markers enabling the identification of the most competent ones, it is…
- Trial name
- PIF-SET1 (NCT01803893)
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 500 people
- Sponsor
- BioIncept LLC
Catheter Complications
SmartPICC-1 Feasibility Study Technical Feasibility Study
The primary objective of this study is to evaluate the safety and technical feasibility of the Piccolo Medical SmartPICC System, indicated for guidance and positioning of commercially available central venous catheters, for PICC…
- Trial name
- NCT05548192
- Testing
- SmartPICC-1 System
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Piccolo Medical
Total Knee Replacement, Total Knee Arthroplasty
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)).
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain
- Trial name
- NCT02468934
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- SPR Therapeutics, Inc.
Failed Back Surgery Syndrome
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from…
- Trial name
- NCT01711619
- Testing
- subcutaneous nerve stimulation, Optimized Medical Management
- Where
- 26 sites in Australia, Austria and 8 more
- Volunteers
- 162 people
- Sponsor
- MedtronicNeuro
Complication, Prosthesis Durability
SEBBIN Silicone Gel-filled Testicular Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device.
- Trial name
- NCT04968470
- Where
- 2 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Groupe SEBBIN
Urinary Incontinence
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
- Trial name
- NCT00080470
- Testing
- bion
- Where
- 11 sites in United States
- Volunteers
- 148 people
- Sponsor
- Boston Scientific Corporation
End Stage Renal Disease
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized…
- Trial name
- NCT06516653
- Testing
- VasQ, Arteriovenous fistula creation for dialysis vascular access
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Laminate Medical Technologies
Breast Implant; Complications
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.
- Trial name
- IM02 (NCT04968457)
- Volunteers
- 908 people, healthy volunteers welcome
- Sponsor
- Groupe SEBBIN
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
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Pregnancy
Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome
PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta. Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention.
- Trial name
- PIFBlood1 (NCT01805102)
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 500 people
- Sponsor
- BioIncept LLC
Contraception, Menorrhagia
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
- Trial name
- NCT00393198
- Testing
- Levonorgestrel (Mirena, BAY86-5028), Cytotec
- Where
- 17 sites in Finland, France and 2 more
- Volunteers
- 204 people
- Sponsor
- Bayer
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Diabetes Mellitus, Diabetes Mellitus, Type 1
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Diabetic
- Trial name
- NCT05597605
- Testing
- The SHINE SYSTEM
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 6 people
- Sponsor
- Indigo Diabetes NV
Distal Fibular Fracture, Bimalleolar Fracture
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus…
- Conditions
- Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture
- Trial name
- NCT00864877
- Testing
- biodegradable fixation system (Inion OTPS FreedomPlateTM)
- Where
- United Kingdom
- Sponsor
- Inion Oy
Catheter Related Complication
Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization: A Pilot Study
The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.
- Trial name
- NCT04811430
- Testing
- Randomized Traditional, Cue(TM) Needle Tracking Technology
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Becton, Dickinson and Company
Stress Urinary Incontinence
Desara ® One Single Incision Sling 522 Study
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
- Trial name
- NCT04772131
- Testing
- Desara® One Single Incision Sling, Desara® Blue Transobturator Sling
- Where
- 15 sites in United States
- Volunteers
- 300 people
- Sponsor
- Caldera Medical, Inc.
Overactive Bladder
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
- Trial name
- NCT04115228
- Testing
- Implantation and neuromodulation therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nine Continents Medical, Inc.