Clinical trials: Implantation 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.
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
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
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
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
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
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
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.
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
Pain, Postoperative
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores
This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale…
- Trial name
- NCT04104919
- Testing
- Brivoligide Injection 660 mg/6 mL
- Sponsor
- Adynxx, Inc.
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
Aneuploidy, Chromosome Abnormality
RCT Study to Validate niPGT-A Clinical Benefit.
Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation.
- Conditions
- Aneuploidy, Chromosome Abnormality, Infertility
- Trial name
- niPGT-A_RCT (NCT04000152)
- Testing
- niPGT-A, Morphology criteria
- Where
- 8 sites in Argentina, Brazil and 3 more
- Volunteers
- 296 people
- Sponsor
- Igenomix
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.
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.
Urethral Stricture
Bioengineered Collagen Implant for Urethral Stricture Repair
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral…
- Trial name
- NCT05463991
- Testing
- Bioengineered collagen implant
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- Regenosca SA
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.
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
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics