Clinical trials: Implant Therapy
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with…
- Trial name
- QUARTO_III (NCT02476201)
- Testing
- MPP ON
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Abbott Medical Devices
Macular Edema, Cystoid Macular Edema
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema after plaque radiotherapy of uveal melanoma.
- Conditions
- Macular Edema, Cystoid Macular Edema, Uveal Melanoma, Radiation Maculopathy
- Trial name
- NCT01471054
- Testing
- Ozurdex, Bevacizumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Arman Mashayekhi
Type 1 Diabetes
Medtronic MiniMed Implantable Insulin Pump
This research is being done to find out whether subjects previously treated with the implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit from re-implantation of IIP.
- Trial name
- NCT00298740
- Testing
- Aventis U-400 Insulin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University
Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma
Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II…
- Conditions
- Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Fatigue, Neurotoxicity Syndrome
- Trial name
- NCT00807768
- Testing
- 3-Dimensional Conformal Radiation Therapy, Carboplatin, Intensity-Modulated Radiation Therapy
- Where
- 540 sites in United States, South Korea
- Volunteers
- 601 people
- Sponsor
- Gynecologic Oncology Group
Chronic Pain
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
- Trial name
- NCT01665040
- Testing
- Neurostimulation device implantation
- Where
- 7 sites in Australia, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
MPS I
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I
The purpose of the study is to evaluate the safety, tolerability of ascending doses of SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing.
- Trial name
- NCT02702115
- Testing
- SB-318
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Sangamo Therapeutics
Chronic Pain, Back Pain
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
- Trial name
- VERITAS (NCT03251937)
- Testing
- Spectra WaveWriter SCS System
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Boston Scientific Corporation
Total Unilateral Deafness, Unilateral Partial Deafness
Cochlear Implantation for Treatment of Single-sided Deafness
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).
- Trial name
- NCT02532972
- Testing
- Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dr. Daniel Lee
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if photodynamic therapy has an effect on bacterial skin colonization and decrease number of…
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Trial name
- PHOMIC (NCT04067843)
- Testing
- Photodynamic treatment
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Degeneration; Bone
Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®)…
- Trial name
- NCT01012921
- Testing
- barrier membrane, MembraGel, Bio-Gide® membrane
- Where
- 9 sites in Belgium, Germany and 5 more
- Volunteers
- 117 people
- Sponsor
- Institut Straumann AG
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Dental Implant
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.
- Trial name
- NCT01211288
- Testing
- Astra implants
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting.
- Trial name
- ENTRUST-AF-PCI (NCT02866175)
- Testing
- Edoxaban, Clopidogrel, Prasugrel
- Where
- 200 sites in Austria, Belgium and 16 more
- Volunteers
- 1,506 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Time, Patient Preference
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in…
- Trial name
- NCT02995369
- Testing
- DryShield, Cotton rolls
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Montefiore Medical Center
Pleural Effusion
Catheter Placement for Hepatic Hydrothorax
The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy.
- Trial name
- NCT02595567
- Testing
- Indwelling tunneled pleural catheter (ITPC)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine