Determine the Proportion of Patients With Disabling Post Thrombotic Syndrome (Moderate or Severe) in the Long Term Within the Cohort of Patients Who Participated in the Trial CELEST Therapy.
The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.
The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.
Study of the Effect of an Elastic Compression Medical Device (Prototype), on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by the occurrence of abnormally frequent episodes of interrupted ventilation (apnea) or significant reduction of ventilation (hypopnea) during sleep. It is linked to a repeated collapse of the upper airways during sleep.
Episodes of apnea and hypopnea cause hypoxemia and micro-awakenings with a well-established impact on quality of life and daily activities. Physiologically, OSAHS can be aggravated when moving from a standing to a supine position through fluid shift from the lower limbs to the upper body, thereby modifying the opening of the upper airways. A decrease of the water balance by bilateral diurnal compression of the lower limbs (during daytime in standing position) may limit this nocturnal fluid shift (at night in supine position) and thus reduce the severity of OSAHS.
Two comparative clinical trials [Redolfi 2011; White 2015] have shown a clinically modest reduction of sleep apnea (-36% and -27%, respectively), which was however statistically significant versus untreated control group (p = 0.002 and p = 0.04, respectively), when elastic compression medical devices of 20 to 30 mmHg were worn during the daytime. The hypothesis of fluid shift influence on OSAHS has been tested [Berg 1993; Redolfi 2011; White 2015], but the decrease of the water balance when the device is used remains to be quantified.
The CVE101-15 exploratory clinical investigation sponsored by Laboratoires Innothera performed on healthy volunteers confirmed the hypothesis of a diuretic effect of elastic compression stockings applying a pressure of 33 mmHg at the ankle, worn for 13-14 hours during the daytime for 3 days, with a good safety profile of this device. Moreover, it enabled the identification of reliable parameters and the endpoints to be used to demonstrate a diuretic effect.
Based on this information, there may be a real interest in conducting further investigations about the evolution of water balance beyond a 3-day period of elastic compression use in the daytime.
Hence, the main objective of this clinical investigation is to compare precisely, under standardized test conditions, water balance changes in healthy subjects over 5 days with or without daytime use of the investigational medical device (IMD), an elastic compression device prototype specially designed for this study.
Study of the Effect of Class III Elastic Venous Compression Focused on 33 mmHg on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study
The main objective of this study is to compare precisely, under standardized test conditions, water balance changes in healthy subjects with or without the daytime use of compression stocking.
100 Clinical Results associated with Laboratoires INNOTHERA
0 Patents (Medical) associated with Laboratoires INNOTHERA
30 Sep 2004·Archives of Physiology and Biochemistry
Venous flow rate in the common femoral vein during activities of the muscles in the lower limb
Author: Aubert, J. T. ; Chabran, E. ; Maton, B.
30 Sep 2004·Archives of Physiology and Biochemistry
Equivalent newtonian viscosity of blood: application to venous confluences
Author: Cros, F. ; Flaud, P. ; Dantan, Ph
30 Sep 2003·Archives of Physiology and Biochemistry
Validation of a 1-D numerical model of thoracic-abdominal pump
Author: Chenuil, A. ; Fullana, J.-M. ; Ribreau, C.
100 Deals associated with Laboratoires INNOTHERA
100 Translational Medicine associated with Laboratoires INNOTHERA