The Experts below are selected from a list of 221733 Experts worldwide ranked by ideXlab platform
Riccardo Bertolo - One of the best experts on this subject based on the ideXlab platform.
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robotic urologic surgical interventions performed with the single port dedicated platform first Clinical Investigation
European Urology, 2019Co-Authors: Jihad H Kaouk, Juan Garisto, Riccardo BertoloAbstract:We report the first Clinical Investigation for surgical procedures performed using the da Vinci SP robotic surgical platform (Intuitive Surgical, Sunnyvale, CA, USA) during the first 10 days (September 28-October 12, 2018) after the system was installed at our institution. The aim of the study was to determine the feasibility and safety of major urologic procedures, measured as the rate of conversions and the incidence of perioperative complications. Secondary aims of the study consisted of key perioperative surgical outcomes, including operative time, blood loss, and length of stay. Pathology data were reported. Data collection was performed under institutional review board approval (IRB 13-780). A total of nine patients were treated (3 robot-assisted radical prostatectomies, 3 transperitoneal robot-assisted partial nephrectomies, 1 simple cystectomy with intracorporeal ileal conduit urinary diversion, 2 ureteral reimplantations). No intraoperative complications occurred. In six cases the surgeries were performed according to a pure single-site approach. The mean operative time was slightly longer than that reported for the corresponding multiarm robotic procedures in the literature, which can easily be explained by the expected learning curve. One minor and one major complication occurred. A learning curve exists when embarking with this surgery. Further Investigations are awaited.
M Junger - One of the best experts on this subject based on the ideXlab platform.
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reducing wound pain in venous leg ulcers with biatain ibu a randomized controlled double blind Clinical Investigation on the performance and safety
Wound Repair and Regeneration, 2008Co-Authors: Finn Gottrup, Bo Norregaard Jorgensen, Tonny Karlsmark, Gary R Sibbald, Rytis Rimdeika, Keith Harding, Patricia Elaine Price, Vanessa Venning, Peter Vowden, M JungerAbstract:Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind Clinical Investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive—comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1–5 (double blind) and days 43–47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofenfoam group, as compared with the comparator on day 1–5, with a quick onset of action (p < 0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1–5 with 40% from baseline, compared with 30% with the comparator (p < 0.001). At day 43–47, the patients in the ibuprofen-foam group had a significant (p < 0.05) reemergence of persistent pain and pain at dressing change (p < 0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.
Robert A Stockley - One of the best experts on this subject based on the ideXlab platform.
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progression parameters for emphysema a Clinical Investigation
Respiratory Medicine, 2007Co-Authors: Jan Stolk, Hein Putter, Els Bakker, Saher B Shaker, David G Parr, Eeva Piitulainen, Erich W Russi, Elzbieta Grebski, Asger Dirksen, Robert A StockleyAbstract:In patients with airflow limitation caused by cigarette smoking, lung density measured by computed tomography is strongly correlated with quantitative pathology scores of emphysema, but the ability of lung densitometry to detect progression of emphysema is disputed. We assessed the sensitivity of lung densitometry as a parameter of disease progression of emphysema in comparison to FEV(1) and gas transfer. At study baseline and after 30 months we measured computed tomography (CT)-derived lung density, spirometry and carbon monoxide diffusion coefficient in 144 patients with chronic obstructive pulmonary disease (COPD) in five different centers. Annual change in lung density was 1.31 g/L/year (CI 95%: -2.12 to -0.50 HU, p=0.0015, 39.5 mL/year (CI 95%: -100.0-21.0 mL, p=0.2) for FEV(1) (-39.5 mL) and 24.3 micromol/min/kPa/L/year for gas transfer (CI 95%: -61.0-12.5 micromol/min/kPa/L/year, p=0.2). Signal-to-noise ratio (mean change divided by standard error of the change) for the detection of annual change was 3.2 for lung densitometry, but 1.3 for both FEV(1) and gas diffusion. We conclude that detection of progression of emphysema was found to be 2.5-fold more sensitive using lung densitometry than by using currently recommended lung function parameters. Our results support CT scan as an efficacious test for novel drugs for emphysema.
Mike Rothera - One of the best experts on this subject based on the ideXlab platform.
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long term stability survival and tolerability of a novel osseointegrated implant for bone conduction hearing 3 year data from a multicenter randomized controlled Clinical Investigation
Otology & Neurotology, 2014Co-Authors: Rik C Nelissen, Maarten J F De Wolf, Stina Wigren, Mans Eegolofsson, Kevin Green, Mark C Flynn, Joacim Stalfors, Mike Rothera, Emmanuel A M MylanusAbstract:OBJECTIVE: To compare the 3-year stability, survival, and tolerability of 2 osseointegrated implants for bone conduction hearing: a wide 4.5-mm-diameter moderately roughened implant with a rounded 6-mm abutment (test) and a 3.75-mm diameter as-machined implant with a conically shaped 5.5-mm abutment (control). STUDY DESIGN: In this randomized, prospective, controlled, multicenter Clinical study, 77 adult patients were included. Test and control implants were randomly assigned in proportions of 2:1. The implants were loaded with the sound processor from 6 weeks postimplantation. Follow-up after surgery was conducted at 10 days; at 4, 6, 8, and 12 weeks; and at 6, 12, 24, and 36 months after surgery. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA), and skin reactions were evaluated according to Holgers' classification. RESULTS: Statistically significantly higher mean ISQ values were recorded for the test implant compared with the control implant at each evaluation time point. Between 2 and 3 years after surgery, ISQ values decreased but remained above baseline values. Implant survival was high for both implants: 96.2% of the test implants and 100% of the control implants survived these 3 years. Statistically significantly improved soft tissue outcomes were observed in the test implant group. CONCLUSION: This extensive long-term Clinical Investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue. The results show that implant loading at 6 weeks is safe.
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stability survival and tolerability of a novel baha implant system six month data from a multicenter Clinical Investigation
Otology & Neurotology, 2011Co-Authors: Catharina A J Dun, Maarten J F De Wolf, Myrthe K S Hol, Stina Wigren, Mans Eegolofsson, Kevin Green, Anneli Karlsmo, Mark C Flynn, Joacim Stalfors, Mike RotheraAbstract:OBJECTIVE: Determination of the difference in implant stability between a novel Baha implant system (test) and the previous-generation implant system (control). METHODS: In an open, randomized, prospective multicenter Clinical Investigation, 77 adult patients with Baha implants were included. Test and control implants were randomly assigned in proportions of 2:1. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, at 4, 6, 8, and 12 weeks, and at 6 months after surgery. Skin reactions were evaluated according to the Holgers classification. Sound processor fitting was performed from 6 weeks after implantation. RESULTS: Significantly higher mean ISQ values, measured between 0 and 6 months, were obtained for test compared to control implants (70.4 versus 65.4, p < 0.0001). Statistically significant differences were obtained for the study population as a whole and for the subgroup of patients loaded at 6 +/- 1 weeks after implant surgery (63.6% of patients). Up to 12 weeks, Holgers rates were comparable, whereas at 6 months, more skin reactions (Grades 1 and 2) were observed in the control implant group. No reduction in mean ISQ values was observed after implant loading. CONCLUSION: The test implant showed higher mean ISQ values at the time of placement and over time. The level of osseointegration reached with the implants in adults as early as 6 weeks after implantation was sufficient to support the sound processor. The test implant system is expected to provide additional benefits related to the improvement of the degree of osseointegration, especially for patients with thin or compromised bone.
Stefania Maggi - One of the best experts on this subject based on the ideXlab platform.
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recommendations for an update of the 2010 european regulatory guideline on Clinical Investigation of medicinal products used in the treatment of osteoarthritis and reflections about related Clinically relevant outcomes expert consensus statement
Osteoarthritis and Cartilage, 2015Co-Authors: Jeanyves Reginster, S Reiterniesert, Olivier Bruyere, Francis Berenbaum, Maria Luisa Brandi, Jaime Branco, Jeanpierre Devogelaer, G Herrerobeaumont, J A Kanis, Stefania MaggiAbstract:Summary Objective The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on Clinical Investigation of drugs used in the treatment of osteoarthritis (OA). Design Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. Results It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during Clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related Clinical need and expected time response to these drugs – i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter – in the timing of assessments. Secondly, values above which a benefit over placebo should be considered Clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). Conclusions This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA.