Clinical trials: Implant Complication
Overactive Bladder
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.
- Trial name
- TITAN 1 (NCT04873271)
- Testing
- Medtronic Implantable Tibial Neuromodulation (TNM) System
- Where
- 7 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MedtronicNeuro
Female Infertility, Oocyte Competence
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo…
- Conditions
- Female Infertility, Oocyte Competence, Mitochondria, Recurent Implantation Failures
- Trial name
- NCT07066267
- Testing
- Experimental
- Where
- Sri Lanka
- Volunteers
- 20 people
- Sponsor
- Sunkaky Medical Cooperation
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
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction
- Trial name
- STEPS A (NCT03356132)
- Testing
- Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Where
- Brazil
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Pain, Postoperative, Hernia, Ventral
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open…
- Conditions
- Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy
- Trial name
- NCT04785638
- Testing
- INL-001 (bupivacaine hydrochloride) implant
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innocoll
Breast Implant Rupture, Breast Implant; Complications
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
- Trial name
- ELEGANT (NCT05987475)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Euromi Biosciences
Uncontrolled Hypertension
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
- Trial name
- HD (NCT05352425)
- Testing
- MobiusHD
- Sponsor
- Vascular Dynamics, Inc.
Urinary Incontinence
Augmenting Urinary Reflex Activity: Study 3
AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.
- Trial name
- AURA-3 (NCT06597994)
- Testing
- Amber UI system
- Where
- Belgium
- Volunteers
- 11 people
- Sponsor
- Amber Therapeutics Ltd
Hernia, Postoperative Pain
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
- Trial name
- NCT01224145
- Testing
- 5x5cm bupivacaine collagen sponges
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Innocoll
PORTs/Peripheral IVs Complication Rates
Post-Marketing Study to Assess Complication Rates of Oncology Patients With Ports and Peripheral IVs
This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.
- Trial name
- VEINSFORLIFE (NCT02792764)
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- C. R. Bard
Renal Artery Stenosis, Hypertension, Renovascular
Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension
The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow by the stent will help to control blood pressure.
- Trial name
- ARTISAN (NCT01673373)
- Testing
- iCAST™ Rx Stent System
- Where
- 12 sites in United States
- Volunteers
- 68 people
- Sponsor
- Atrium Medical Corporation
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Survival, Prosthesis
Monocer AOANJRR Registry-nested Study
This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data…
- Trial name
- NCT05822505
- Where
- Australia
- Volunteers
- 280 people
- Sponsor
- Medacta International SA
Overactive Bladder, Urge Incontinence
AURA-2: Augmenting Urinary Reflex Activity
AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve…
- Trial name
- AURA-2 (NCT05241379)
- Testing
- Amber UI System
- Where
- Belgium
- Volunteers
- 13 people
- Sponsor
- Amber Therapeutics Ltd
Cataract, Anterior Chamber Inflammation
Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery
Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber…
- Conditions
- Cataract, Anterior Chamber Inflammation, Pain, Postoperative
- Trial name
- NCT03180255
- Testing
- Dexamethasone phosphate
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Eyegate Pharmaceuticals, Inc.
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Pain, Postoperative
Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal…
- Trial name
- NCT00749749
- Testing
- Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant), ON-Q PainBuster Post-op Pain relief System
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Innocoll
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
End-stage Renal Disease, Kidney Failure, Chronic
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
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
- NCT01744418
- Testing
- HAVG graft implantation
- Where
- 3 sites in Poland
- Volunteers
- 40 people
- Sponsor
- Humacyte, Inc.
Dental Prosthesis Failure, Dental Prosthesis Complication
Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
This is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns.
- Trial name
- NCT05752539
- Testing
- CEREC System by Dentsply Sirona
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd