Clinical trials: Safety and Performance
Arterial Embolization
Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas.
- Trial name
- Ideale (NCT02863133)
- Testing
- Liquid Embolic
- Volunteers
- 65 people
- Sponsor
- Antia Therapeutics AG
Acute Ischemic Stroke
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
- Trial name
- SPLENDID (NCT06386289)
- Testing
- Cereglide 92
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Artery Stenosis, Carotid, Artery Stenosis
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Trial name
- NCT04643743
- Testing
- Endarterectomy
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Perouse Medical
Heart Failure
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure
- Trial name
- NCT02633644
- Testing
- Harmony System
- Where
- 5 sites in Belgium, Croatia and 2 more
- Volunteers
- 30 people
- Sponsor
- Enopace Biomedical
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Edentulous Mouth
Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants
- Trial name
- NCT05375045
- Testing
- dental implantation
- Where
- France
- Volunteers
- 868 people
- Sponsor
- Euroteknika
Acute DeBakey I Aortic Dissection, Intramural Hematoma
DARTS I: Feasibility, Safety, and Performance Trial
The objective of this study is to investigate the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ascending aorta and aortic…
- Trial name
- DARTS I (NCT03397251)
- Testing
- AMDS
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Ascyrus Medical LLC.
Cardiovascular Diseases
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting…
- Trial name
- NCT06412250
- Where
- 32 sites in India, Italy and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Translumina Therapeutics Pvt Ltd.
Wounds
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the…
- Trial name
- NCT06083740
- Testing
- Granudacyn/Veriforte
- Where
- Austria
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- P.G.F. Industry Solutions GmbH
Sacrocolpopexy
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
- Trial name
- SPARO (NCT07031050)
- Testing
- sacrocolpopexy or sacrocervicopexy
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 35 people
- Sponsor
- Distalmotion SA
Edentulous Maxilla, Maxillary Bone Loss
NobelZygoma TiUltra Implant System Study
The goal of this prospective study is to assess short term (12-months) clinical outcomes of NobelZygoma TiUltra implants and Multi-unit Abutment Xeal in the rehabilitation of participants with severely atrophic maxilla treated…
- Conditions
- Edentulous Maxilla, Maxillary Bone Loss, Atrophic Maxilla
- Trial name
- NCT07258940
- Testing
- NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant, Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP
- Where
- 2 sites in Italy, Switzerland
- Volunteers
- 85 people
- Sponsor
- Nobel Biocare
Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent
MultiPulse Therapy (MPT) for AF
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent, Atrial Fibrillation
- Trial name
- NCT04206917
- Testing
- Multi Pulse Therapy
- Where
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Cardialen, Inc.
Coronary Artery Disease, Coronary Restenosis
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of…
- Conditions
- Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Trial name
- AGENT-ISR (NCT02151812)
- Testing
- Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
- Where
- 12 sites in France, Germany
- Volunteers
- 123 people
- Sponsor
- Hemoteq AG
Chronic Low Back Pain (CLBP)
Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020.
- Trial name
- LumbaCure2302 (NCT06662032)
- Testing
- LumbaCure®, Rehab program
- Where
- 2 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- Odix
Skin Aging, Skin Wrinkling
Evaluation of the Safety and Performance Characteristics of Mesofiller Mesotox for the Correction of Wrinkles and Rehydration of the Face.
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for the evaluation of the safety and performance of the product mesofiller® mesotox…
- Trial name
- NCT06477432
- Testing
- mesofiller® mesotox
- Where
- Bulgaria
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Mesoestetic Pharma Group S.L.
Tricuspid Regurgitation
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation.
- Trial name
- NCT07334691
- Testing
- Cardiovalve TR valve replacement System
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Cardiovalve Ltd.
Polyp of Large Intestine
Microwave Coagulation Using CROMA Electrosurgical System
This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.
- Trial name
- NCT02372552
- Testing
- CROMA
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Creo Medical Limited
Osteoarthritis, Knee, Rheumatoid Arthritis of Knee
Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis
- Trial name
- NCT03224689
- Testing
- PEEK-Optima Femoral Component
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Maxx Orthopedics Inc
Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
- Trial name
- PUL (NCT02106351)
- Testing
- Botulinum toxin type A
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 212 people
- Sponsor
- Ipsen
Knee Osteoarthritis
Cellular Matrix Device for the Treatment of Mild to Moderate Knee Osteoarthritis
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to…
- Trial name
- NCT03328728
- Testing
- Cellular Matrix / A-CP HA Kit, Synvisc-One
- Where
- France
- Volunteers
- 190 people
- Sponsor
- Regen Lab SA
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