Guilherand Granges

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Found 6 Actively Recruiting clinical trials

C

RECRUITING

The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

18+ yearsFEMALE
2 locations
C

RECRUITING

Standard treatment option of intermediate risk (ISUP2) prostate cancer (PC) is either radical prostatectomy (RP) or radiation therapy (RT). An attractive option for selected patients and for the health care system would be to spare the preserved gland to decrease urinary, sexual and digestive side effects of whole-gland treatments keeping with a good cancer control. For these reasons, focal treatments have been developed in localized PC. The principal objective of the EMERHIT study is to estimate, from the health system point of view, the efficiency (cost/utility study) of focal HIFU (F-HIFU) for intermediate risk PC compared to RP (either by open, laparoscopic or robotic surgical approach) at 24 months. It will be a multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups : * (1) F-HIFU treatment * (2) RP Randomization will be equal (ratio 1:1), stratified on the centers and performed maximum at 2 months before the procedure. The comparison to the SNDS data will use the NIR of the patients selected for the study. The use of the SNDS data will allow, on top of the estimation of the care cost, to increase the patient's follow-up (with no supplemental visit) and measure, at 48 months, costs, mortality rate and cancer control measures From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.

50-75 yearsMALENA
20 locations
D

RECRUITING

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

18+ yearsAll GendersPHASE2
34 locations
P

RECRUITING

The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling). The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma. The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits. Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).

18+ yearsAll GendersNA
5 locations
S

RECRUITING

It is admitted that: * Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction, * Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes, * Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures, * Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis. Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined. This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use. Studied products include - but are not restricted to - the following TEKNIMED products: * EUROSCREW® NG * ISOFIX® * SUTUR'LINK® * A'LINK'S® * BIORESORBABLE PINS And following associated TEKNIMED instrumentation: * ACL Instrumentation * A'LINK'S® Instrumentation * STAINLESS STEEL PINS

18+ yearsAll Genders
10 locations
S

RECRUITING

Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty. The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded. The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years. The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.

All Genders
13 locations
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