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Consultez nos réalisations publiques depuis 2021.
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Consultez nos réalisations publiques depuis 2021.
Contactez-nous pour plus d’exhaustivité dans nos réalisations cliniques.
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA. (MERLIN)
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.
If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
Début : 14 août 2024
Étude en cours
Feasibility pilot study to evaluate the Safety and Performance of the MEX-CD1 medical device in Acute-on-Chronic Liver Failure (ACLF). (MexACLF)
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:
- Is the device safe when used according to the instructions for use?
- Does the device work as expected by removing the excess of free iron from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
Début : 21 juin 2024
Étude en cours
Performance and Safety evaluation of the FHK®-CK knee prosthesis indicated for the treatment of primary and secondary first line gonarthrosis and revision arthroplasty – 2 years follow-up» - A Pilot Study. (FHK-CK)
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked).
Début : 1er février 2024
Étude en cours
Impact de la validation par le patient traité par PPC des alertes transmises via les outils de télésuivi (Alertes Observance, Fuites et IAH). (IPIAM)
IPIAM is a prospective randomized controled study with two arms. Two approaches to telemonitoring will be compared: the standard telemonitoring carried out by the home healthcare provider (standard of care) will be compared with a new approach in which the patient is involved in managing his treatment by collecting vitals and notifying alerts via two connected devices (a connected watch and a mobile application).
Début : 29 septembre 2023
Étude en cours
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases (OPHTAI-EVAL)
Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.
Début : 28 juin 2023
Étude en cours
Performance et sécurité des tiges Flex+2® chez des patients souffrant de troubles symptomatiques de la colonne vertébrale associés à une lombalgie (DYNAMIC)
Collecte de données cliniques post-commercialisation visant à confirmer la performance et la sécurité du dispositif Flex+2®, tige dynamique et hybride, chez des patients souffrant de troubles symptomatiques de la colonne vertébrale associés à une lombalgie… . L’étude porte sur des hommes ou des femmes, de 18 ans et plus, souffrant de pathologies liées à la discopathie dégénérative associée à une lombalgie. Pathologie confirmée par l’imagerie, ce sont des patients pour lesquels les traitements conservateurs sont restés inefficaces et pour qui l’intervention chirurgicale avec implantation de tiges Flex +2® reste une solution.
Début : 15 mai 2023
Étude en cours
Safety and performance of the SpineVision posterior fixation systems LMUIS™, PLUS® and ULIS™ in thoracolumbar spinal degenerative pathologies or DDD associated pathologies treatment (FIXED D3)
Collecte de données cliniques post-commercialisation visant à confirmer la sécurité et la performance des systèmes de fixation postérieure de SpineVision : LUMIS™, PLUS® et ULIS™ dans le traitement des pathologies dégénératives rachidiennes thoraco-lombaires ou de pathologies associées à la Discopathie Dégénérative – Étude Fixed D3
Début : 1er octobre 2022
Étude en cours
Oxygen Therapy Remote Monitoring in COPD Patients.
Background : Long-term oxygen therapy is prescribed for patients with severe COPD. The aim of oxygen therapy is to administer oxygen at a concentration level higher than that of ambient air, in order to treat or prevent the symptoms and manifestations of arterial hypoxemia; this therapy can be applied either in an acute situation or as a long-term treatment, in cases of stabilized severe chronic hypoxemia.
Début : 1er octobre 2022
Étude en cours
Étude rétrospective longitudinale en vie réelle évaluant la qualité du traitement par Pression Positive Continue chez des patients atteints d’un Syndrome d’Apnées du Sommeil et télésuivis durant une année (eQUALISAS).
La finalité de cette recherche rétrospective en vie réelle est d’analyser des données de télésuivi de patients atteints d’un SAS sévère afin de mieux comprendre/identifier les facteurs matériels (machines PPC et types de masques) qui impactent la qualité du traitement par PPC (en termes d’observance, de niveau de fuites non-intentionnelles, d’IAH résiduel). Les résultats de cette étude devront permettre d’améliorer la prise en charge du patient télésuivi traité par pression positive continue
Début : 20 juillet 2022
Traitement des données
Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group).
The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction.
Début : 25 janvier 2022
Étude terminée
Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.
The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.
Début : 30 juin 2021
Étude terminée
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.
Début : 22 juin 2021
Étude terminée
Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial. (RETRACT)
The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.
Début : 10 mai 2021
Étude terminée
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
Dyslexia is defined as a specific learning disability that is characterized by reading difficulties, in the absence of intellectual disability, neurological or psychiatric disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency. Recently, following work published in 2017, an anatomical cause based on Maxwell’s spots could also be a cause of dyslexia.
The aim of this study is to evaluate a new medical device (class I CE marked) to compensate this probable anatomical cause: the Atoldys/ Lexilens glasses
Début : 19 janvier 2021
Étude terminée
Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education.
Début : 18 janvier 2021
Réalisation clinique terminée
Traitement des données
Study of Physiological Signals During and After COPD Exacerbations (DACRE)
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.
Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.
Début : 15 janvier 2021
Étude terminée
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial (OPTIFILL)
Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.
Début : 6 novembre 2020
Étude en cours
Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain (ABC-TRACC)
The objective is to optimize the three key phases followed by the healthcare professional: teaching his patient to feel the contraction of the muscle, learning to control this contraction, then learning to master this contraction when the patient is in double task (movements rehabilitation targeting other muscles, cognitive tasks or other tasks of everyday life that strain the spine).
In the ABC-TRACC study, the objective is to compare the time needed for patient to get a good motor control on his transversus abdominal muscle if he is using the Blueback® Physio during his sessons or not.
Début : 15 octobre 2020
Étude terminée
Follow Fever to Decide : Détermination d’un algorithme permettant de quantifier et qualifier la rythmicité circadienne. (F2D)
Body temperature is one of the markers of biological rhythms. The precise determination of the functioning of the biological clock for an individual is essential to understanding his physiological state at a given time. This condition is dependent on the “timing” of its central clock on the time scale (chronotype). The provision of a simple-to-use (F2D cuff), non-invasive and time-dependable temperature tool and the creation of appropriate algorithms would allow access to the operation of the central clock and open up many therapeutic applications.
Début : 13 mars 2020
Étude terminée
Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease
The main objective is this observational study is to monitor the home NIV compliance over a period of 1 year under real conditions of treatment in patients with COPD newly initiated onto NIV (with telemonitoring or not) in order to specify the predictive criteria for good compliance. The secondary objectives are to assess the evolution of functional respiratory data, NIV parameters and changes in prescription, occurrence of acute exacerbations of COPD, hospitalizations and death, patient outcomes (quality of life and acceptability of NIV).
Début : 25 février 2020
Étude terminée
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients (DysLight)
To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms and disorders associated with dyslexia does not facilitate the identification of precise neurobiological / psycho cognitive mechanisms. There are therefore several theories: phonological, visual, temporal, cerebellar or proprioceptive auditory processing. Recently, following work published in 2017, an anatomical cause based on Maxwell’s spots could also be a cause of dyslexia.
The aim of this study is to evaluate a new medical device to compensate this probable anatomical cause.
Début : 18 décembre 2019
Étude terminée
Post Marketing Study for the Evaluation of Predictix Antidepressant Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.
Début : décembre 2019
Étude terminée
Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.
The association between heart failure and Cheynes-Stokes respiration is known and a recent study showed that Cheynes-Stokes respiration was associated with more severe heart failure. Moreover, a medical and medical/financial benefit of the early detection of cardiac decompensation has been reported.The purpose of this feasibility study is to investigate the benefit of Cheyne-Stokes respiration remote monitoring in CPAP-treated patients with OSA for the early detection of significant cardiac events (heart failure, rhythm disorder, diastolic dysfunction).
Début : 30 juillet 2018
Étude terminée
Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.
Début : 22 mai 2018
Étude terminée