Clinical trials: Implant Complication
Infertility, Endometritis
Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization
Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is asymptomatic or little symptomatic.
- Conditions
- Infertility, Endometritis, Abortion, Spontaneous
- Trial name
- NCT01762098
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Clinique Ovo
Vascular Access Complication
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
- Trial name
- NCT00914069
- Testing
- RIVS vascular access, Conventional vascular access
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Cystocele
Nerve Access Tool Study
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
- Trial name
- NCT00942474
- Testing
- Facilitate nerve stimulation lead placement with the nerve access tool
- Sponsor
- MedtronicNeuro
Complication, Prosthesis Durability
SEBBIN INTEGRITY Round Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device.
- Trial name
- NCT05642390
- Testing
- Breast implant
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Groupe SEBBIN
Overactive Bladder
Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
- Trial name
- TITAN 2 (NCT05226286)
- Testing
- Medtronic Implantable Tibial Neuromodulation (TNM) System
- Where
- 29 sites in United States
- Volunteers
- 188 people
- Sponsor
- MedtronicNeuro
Systemic Symptoms, Breast Implant Illness
Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction.
- Conditions
- Systemic Symptoms, Breast Implant Illness, Breast Implant Complications
- Trial name
- NCT07810803
- Testing
- Silicone Breast Implant Exposure, Standardized Systemic Symptom and Psychosocial Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Anemia, End Stage Renal Disease
Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant
In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo.
- Trial name
- NCT01555515
- Testing
- implantation of autologous skin graft after ex-vivo treatment, Subcutan implantation of autologus skin graft after ex-vivo treatment
- Volunteers
- 4 people
- Sponsor
- Medgenics Medical Israel Ltd.
End Stage Renal Disease
A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding…
- Trial name
- NCT01644526
- Testing
- Hemoaccess Valve System
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Diaxamed LLC
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Overactive Bladder
Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1
Interventional, Prospective, Open Label study
- Trial name
- OPTIMIST-1 (NCT03019094)
- Testing
- The RENOVA tibial nerve stimulation system
- Sponsor
- BlueWind Medical
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
End-stage Renal Disease, Kidney Failure, Chronic
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01840956
- Testing
- HAVG
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Humacyte, Inc.
Urinary Incontinence,Stress
ARTUS MONO Artificial Urinary Sphincter
The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff…
- Trial name
- NCT03703843
- Testing
- ARTUS MONO
- Where
- 2 sites in Czechia, France
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Myopowers Medical Technologies France SAS
Recurrent Miscarriage, Infertility
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.
- Trial name
- BlastGen (NCT02305420)
- Testing
- EmbryoGen/ BlastGen media, Standard Cook sequential media
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- FertilitySA
Chronic Sinusitis
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of: Sinus tissue adhesions Middle…
- Trial name
- NCT02812199
- Testing
- Composite Removable Sinus Stent, adrenaline-lidocaine, cold saline wash
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- STS Medical
Premature Birth, Placenta Previa
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm)…
- Trial name
- NCT01442207
- Testing
- Placement of a Cervical Cerclage, Standard Expectant Management
- Volunteers
- healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Total Knee Replacement, Total Knee Arthroplasty
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard…
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain
- Trial name
- NCT03286543
- Testing
- SPRINT Beta System
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- SPR Therapeutics, Inc.
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard