Clinical trials: Implant Complication
Hemorrhagic Complications, Hematoma
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation…
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Trial name
- PacePress (NCT05292326)
- Testing
- PacePress, standard compression band
- Where
- 7 sites in Poland
- Volunteers
- 122 people
- Sponsor
- Medinice S.A.
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
Overactive Bladder (OAB)
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
A study to evaluate the safety and effectiveness of FemPulse System
- Trial name
- EVANESCE-II (NCT07195656)
- Testing
- Device Group, Medication Group
- Where
- 15 sites in United States
- Volunteers
- 151 people
- Sponsor
- FemPulse Corporation
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
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
Overactive Bladder
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.
- Trial name
- NCT00131573
- Testing
- bion
- Where
- 11 sites in United States
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation
Urinary Bladder, Overactive
FemPulse Therapy for Overactive Bladder in Women
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
- Trial name
- EVANESCE-OAB (NCT03784170)
- Testing
- FemPulse System
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- FemPulse Corporation
End Stage Renal Failure, Hemodialysis, Cannulation
Guided Needle Insertion for Vascular Access
The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.
- Trial name
- ACCESS 2 (NCT07548151)
- Testing
- Ultrasound-Guided, Power-Assisted Needle Insertion
- Where
- Uzbekistan
- Volunteers
- 10 people
- Sponsor
- X9, Inc.
Endometriosis
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
- Trial name
- NCT06543550
- Testing
- Implantable gestrinone, Oral Dienogest
- Where
- 4 sites in Brazil
- Volunteers
- 70 people
- Sponsor
- Bio Meds Pharmaceutica Ltda
Blood Loss, Surgical
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
- Trial name
- NCT06647017
- Testing
- Volta tAN System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University Surgical Vascular
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.
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
Ischemic Stroke, Ischemia
Biomarkers of Acute Stroke in Clinic
The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic…
- Conditions
- Ischemic Stroke, Ischemia, Atrial Fibrillation, Transient Ischemic Attack
- Trial name
- BASIC (NCT03897478)
- Testing
- ISCDX blood test
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Ischemia Care LLC
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
Kidney Diseases, Arteriovenous Fistula
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
- Trial name
- NCT04896476
- Testing
- EchoMark / EchoSure
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sonavex, Inc.
Early Pregnancy, Early Pregnancy Loss
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
EARLY-PREG is an open-cohort clinical study with a preconception, longitudinal, bidirectional and counterfactual design. The aim of this cohort is to investigate the proteomic signatures of maternal-embryonic communication by…
- Conditions
- Early Pregnancy, Early Pregnancy Loss, Childbirth, Healthy
- Trial name
- EARLY-PREG (NCT07358026)
- Testing
- EMBRYO EXPOSURE
- Where
- Chile
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- MELISA Institute Genomics & Proteomics Research SpA
Contact Lens Complication, Debris in Post Lens Tear Reservoir
Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
- Trial name
- NCT03525704
- Testing
- Saline Solution Enriched, Saline Rinse Solution
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Contamac Ltd
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
Postoperative Pain, Inguinal Hernia
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
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 24 hours after herniorrhaphy.
- Trial name
- NCT00626886
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Innocoll
Urge Incontinence
Protect Chronic Tibial Nerve Stimulator (CTNS) System
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
- Trial name
- NCT02781636
- Testing
- Device: StimGuard Protect System
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Uro Medical Corporation