Pelvic Organ Prolapse — Development Study Using Vaginal Tactile Imager
Citation(s)
Egorov V, Patel M, Sarvazyan AP Vaginal tactile imager for direct tissue elasticity modulus estimation. Proceedings of the 10th International Tissue Elasticity Conference, Arlington, Texas, October 12-15, 2011:59.
Egorov V, van Raalte H, Lucente V Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. Int Urogynecol J. 2012 Apr;23(4):459-66. doi: 10.1007/s00192-011-1592-z. Epub 2011 Nov 10.
Egorov V, van Raalte H, Lucente V Vaginal tactile imaging: clinical results. Proceedings of the 10th International Tissue Elasticity Conference, Arlington, Texas, Oct 12-15, 2011: 66.
van Raalte H, Egorov V, Lucente V Tactile imaging of pelvic floor changes with age and parity. American Urogynecologic Society: 32nd Annual Scientific Meeting, Providence, Rhode Island, September 14-17, 2011.
van Raalte H, Lucente V, Egorov V 3-D imaging and quantifying vaginal tissue elasticity under normal and prolapse conditions. International Urogynecological Association: 36th Annual Meeting, Lisbon, Portugal, June 28 - July 2, 2011.
A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
