Clinical trials: Safety and Performance
Cardiovascular Diseases, Abdominal Aortic Aneurysm
A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System
This is a prospective multicenter observational study with 20 patients to evaluate the performance of SCITECH stent for treatment of AAA.
- Trial name
- Stent-Graft (NCT01368679)
- Testing
- Endoprothesis Implantation
- Where
- 2 sites in Brazil
- Sponsor
- Scitech Produtos Medicos SA
Pulmonary Embolism
Evaluation of the Safety and Performance of Magneto PE Kit
This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.
- Trial name
- NCT04949048
- Testing
- Magneto PE Kit
- Where
- 5 sites in Denmark, Israel and 1 more
- Volunteers
- 15 people
- Sponsor
- Magneto Thrombectomy Solutions
Veinous, Chemotherapy
A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics…
- Conditions
- Veinous, Chemotherapy, Antibiotics, Antiviral Drugs
- Trial name
- NCT05519761
- Testing
- Implantation of veinous access ports
- Where
- 3 sites in France
- Volunteers
- 250 people
- Sponsor
- Perouse Medical
Peripheral Vascular Interventions
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions.
- Trial name
- ACCESS-PVI (NCT06141694)
- Testing
- The LIBERTY® Robotic System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Microbot Medical, INC
Breast Cancer, Resection Margin
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection
This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection.
- Trial name
- NCT06020573
- Testing
- Clip-on electrode with fiber optics
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Erbe Elektromedizin GmbH
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Peripheral Arterial Disease
The Cre8™ BTK Post Market Clinical Follow-up Study
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.
- Trial name
- NCT05616156
- Testing
- Cre8™ BTK
- Where
- 2 sites in Italy
- Volunteers
- 30 people
- Sponsor
- CID S.p.A.
Prostate Cancer
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence…
- Trial name
- NCT04186845
- Testing
- rhPSMA-7.3 (18F) Injection, Positron emission tomography scan
- Where
- 28 sites in United States, Finland and 1 more
- Volunteers
- 391 people
- Sponsor
- Blue Earth Diagnostics
Osteoarthritis Shoulder, Rheumatoid Arthritis
TESS V3 Modular Total Shoulder System PMCF
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis
- Trial name
- NCT05002959
- Testing
- Anatomic TESS V3, Reverse TESS V3
- Where
- 2 sites in France
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet
Low Back Pain, Recurrent
Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time…
- Trial name
- ABC-TRACC (NCT04592094)
- Testing
- Blueback® Physio
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Blueback
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Sweden Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01667003
- Where
- 8 sites in Sweden
- Volunteers
- 406 people
- Sponsor
- Biotronik ApS
Heart Failure, Cardiac Resynchronization Therapy
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium.
- Trial name
- BIO|REDUCE (NCT03839121)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 21 sites in Austria, Czechia and 2 more
- Volunteers
- 113 people
- Sponsor
- Biotronik SE & Co. KG
Wound Heal, Wound; Foot
Management of Acute and Chronic Wounds With Hyaluronic Acid
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the…
- Trial name
- NCT06108999
- Testing
- Connettivina BIO cream and gauze
- Where
- 3 sites in Italy
- Volunteers
- 170 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Arthritis, Traumatic Arthritis
Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the…
- Conditions
- Arthritis, Traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT05679232
- Testing
- Hydrogel coating, Control
- Where
- Austria
- Volunteers
- 56 people
- Sponsor
- Medacta International SA
Obstructive Sleep Apnea of Adult
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep…
- Trial name
- NCT03048604
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 3 sites in Australia, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Nyxoah S.A.
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
Non-Small Cell Lung Cancer NSCLC
A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients
This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1 inhibitor durvalumab as first-line therapy in 47 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).
- Trial name
- NCT02879617
- Testing
- durvalumab
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Academic Thoracic Oncology Medical Investigators Consortium
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Intracranial Aneurysm
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured…
- Trial name
- SUNRISE-2 (NCT02415010)
- Testing
- Enterprise 2 Vascular Reconstruction Device
- Where
- 10 sites in Germany, Spain and 2 more
- Volunteers
- 26 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
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