ABSTRACT
With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.
Subject(s)
Humans , Bone Cements , Fractures, Compression , Spinal Fractures , Treatment OutcomeABSTRACT
Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.
Subject(s)
Arthroplasty, Replacement, Hip , Clinical Trials as Topic , Hip Prosthesis , Prosthesis Design , Registries , Treatment OutcomeABSTRACT
Objective To investigate effects of rectal cancer to undergo total mesorectal excision (TME)or three space dissection(TSD)with pelvic autonomic nerve preservation(PANP).Methods TME or/ and TSD was applied in 247 Patients with advanced rectal cancer in which 185 cases (74.9 %) underwent PANP(Group P)including TME-PANP(Group Pro)139 cases and TSD-PANP(Group Ps)46 cases.The other 62 cases underwent none-PANP(Group P-)due to tumor invasion.Results There were no death cases for operation inall patients.Group Pm was better than Group Ps in the operation time and the difficulty of proce- dure(P0.05).Conclusion The procedure with TME to preserve pelvic autonomic nerves adapts to the majority of rectal cancer patients.TSD procedure is more complex than TME.Statistically,the survival differ- ence between Patients with TSD and with TME is no defective.The survival time is determined to the tumor's earlier diagnosis and therapy.