Clinical trials: Implant Complication
Urinary Bladder, Overactive
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
- Trial name
- NCT04001426
- Testing
- The FemPulse System
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- FemPulse Corporation
Acute Postoperative Pain
Study Assessing Pain Relief After Replacement of the Knee
This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty.
- Trial name
- SPARK (NCT05260008)
- Testing
- ATX-101, bupivacaine hydrochloride without epinephrine
- Where
- 13 sites in Australia, Canada and 1 more
- Volunteers
- 112 people
- Sponsor
- Allay Therapeutics, Inc.
Colorectal Surgery, Surgical Wound Infection
A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.
- Trial name
- NCT00600925
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 39 sites in United States
- Volunteers
- 602 people
- Sponsor
- Innocoll
Infertility, Female, IVF
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.
- Trial name
- NCT04052464
- Testing
- endometrium biopsy, endometrium lavage, repeated endometrium lavage
- Volunteers
- 67 people
- Sponsor
- Prelife Kft
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
Cataract, Pseudophakia
Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline…
- Conditions
- Cataract, Pseudophakia, Intraocular Lens Complication, Intraocular Lens Opacification
- Trial name
- NCT05750225
- Testing
- Standard of care, Patient satisfaction questionnare
- Where
- 2 sites in Hungary
- Volunteers
- 52 people
- Sponsor
- Medicontur Medical Engineering Ltd
Postoperative Pain
Efficacy and Safety of a Collagen Bupivacaine Implant in Women 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 24 hours after abdominal…
- Trial name
- NCT00624910
- Testing
- Bupivacaine Collagen Sponge (CollaRx®)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Innocoll
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
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
Diabetic Macular Edema
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME).
- Trial name
- NEW DAY (NCT04469595)
- Testing
- Iluvien 0.19 MG Drug Implant, Aflibercept
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Alimera Sciences
Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI)
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
- Conditions
- Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain, Urge Urinary Incontinence
- Trial name
- AURA-4X (NCT06885931)
- Testing
- Pudendal neuromodulation
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 86 people
- Sponsor
- Amber Therapeutics Ltd
Diabetic Neuropathy, Pain
Spinal Cord Stimulation for Painful Diabetic Neuropathy
The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy.
- Conditions
- Diabetic Neuropathy, Pain, Peripheral Neuropathy
- Trial name
- DPN (NCT00487981)
- Testing
- Precision Spinal Cord Stimulation
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Boston Scientific Corporation
Pain, Postoperative
Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours…
- Trial name
- NCT00661466
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Innocoll
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
A Study Assessing AR-13503 Implant in Subjects With nAMD or DME
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
- Trial name
- NCT03835884
- Testing
- AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose, AR-13503 42.4 Dose
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Aerie Pharmaceuticals
Missing Teeth, Prosthesis Survival
Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.
- Trial name
- NCT05649085
- Testing
- Cobalt-Chromium (CoCr) prosthetic abutments
- Where
- Brazil
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Neodent
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.
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.
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC
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.
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