Clinical trials: Safety and Performance
Ischemic Stroke
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
Prospective, single-arm, open label, Safety and Performance clinical investigation.
- Trial name
- NCT02994563
- Testing
- Thrombectomy Device
- Where
- 4 sites in Spain, Sweden
- Volunteers
- 5 people
- Sponsor
- Amnis Therapeutics
Knee Osteoarthritis
Clinical Investigation to Compare the Safety and Efficacy of Cellular Matrix to Those of Ostenil® Plus and to Those of PRP Only
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regenerative medicine.
- Trial name
- NCT02964143
- Testing
- Cellular Matrix / A-CP HA, Ostenil® Plus, RegenKit-BCT-1
- Volunteers
- 306 people
- Sponsor
- Regen Lab SA
Knee Osteoarthritis
sAfety PerfoRmance chitOsan osteOarthritis ViscosupplEmentation
KIO014 is an innovative chitosan-based biomaterial intended for synovial fluid viscosupplementation indicated for the symptomatic treatment of knee osteoarthritis (OA).
- Trial name
- APROOVE (NCT03679208)
- Testing
- Investigational device coded KIO014, Durolane(r) as control device
- Volunteers
- 100 people
- Sponsor
- Kiomed Pharma
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Aesthetic Correction of the Lips
Clinical Investigation on Lips Treated With HA-filler
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
- Trial name
- DAG-ESS (NCT07188818)
- Testing
- Decoria Essence
- Where
- 6 sites in Sweden
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bohus Biotech AB
Breast Tissue Accessory, Breast Cancer
Motiva Flora Tissue Expander PMCF
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of…
- Trial name
- NCT05447988
- Testing
- Breast Tissue Expander
- Where
- 5 sites in Chile, Costa Rica and 2 more
- Volunteers
- 136 people
- Sponsor
- Establishment Labs
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Shoulder Pain, Shoulder Impingement Syndrome
Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in shoulder soft tissue inflammation.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Tendinitis
- Trial name
- SHINE (NCT06759935)
- Testing
- Laser therapy, physiotherapy/exercise protocol
- Where
- 10 sites in France, Italy and 1 more
- Volunteers
- 104 people
- Sponsor
- DJO UK Ltd
Peripheral Nerve Injuries
Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
is is a multi-center, open-label, observational registry study (both prospective and retrospective) designed to evaluate the safety and performance of the allay™ Hydrogel Cap.
- Trial name
- COMPASS (NCT07246980)
- Testing
- Nerve Cap
- Where
- 5 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tulavi Therapeutics,Inc.
Overactive Bladder
Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
- Trial name
- NCT03874780
- Testing
- Vibe Delivery system
- Where
- 2 sites in Czechia, Portugal
- Volunteers
- 10 people
- Sponsor
- Vensica Therapeutics Ltd.
Mitral Valve Insufficiency
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation…
- Trial name
- NCT04343313
- Testing
- Half Moon TMVr System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Half Moon Medical
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Dry Eye, Dry Eye Disease
PMCF Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and…
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Trial name
- NCT05825352
- Testing
- Carmellose eye drops
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Age-related Cataract, Vision Loss
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract
- Trial name
- EB-CE-02 (NCT07246915)
- Where
- 6 sites in Romania
- Volunteers
- 47 people
- Sponsor
- Edinburgh Biosciences Ltd
Cartilage or Osteochondral Defects in the Knee
COPLA® Cartilage Implant Pilot Clinical Trial
This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the COPLA® cartilage implant.
- Trial name
- NCT05685316
- Testing
- COPLA® cartilage implant
- Where
- 6 sites in Estonia, Finland and 1 more
- Volunteers
- 20 people
- Sponsor
- Askel Healthcare Ltd
Rectal Prolapse
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in…
- Trial name
- NCT04130555
- Testing
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Where
- 3 sites in France
- Volunteers
- 55 people
- Sponsor
- Meccellis Biotech
Wide Neck Intracranial Aneurysms
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
- Trial name
- NCT01753388
- Testing
- Liberty Stent
- Where
- 4 sites in Germany
- Sponsor
- Penumbra Inc.
Osteoarthritis, Hip, Rheumatoid Arthritis
Exception Cementless Hip Stem
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia
- Trial name
- Exception (NCT04349046)
- Testing
- Total hip arthoplasty (THA)
- Where
- 6 sites in Belgium, France
- Volunteers
- 332 people
- Sponsor
- Zimmer Biomet
Trapeziometacarpal Osteoarthritis, Rhizarthrosis
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix.
- Conditions
- Trapeziometacarpal Osteoarthritis, Rhizarthrosis, MEDICAL DEVICE, Infiltrate
- Trial name
- SMAGENART (NCT06781554)
- Testing
- MD-Small Joints Collagen Medical Device
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Guna S.p.a
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