Chudnoff SG, Levine DJ, Galen DI, et al Prospective 12-month follow up of quality-of-life improvement following 135 consecutive cases laparoscopic and ultrasound-guided radiofrequency ablation of fibroids. J Minim Invasive Gynecol. 2012;19(Suppl):S45.
Fried MP, Parikh SR, Sadoughi B Image-guidance for endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1287-92. doi: 10.1097/MLG.0b013e31816bce76. Review.
Galen DI Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids. Biomed Eng Online. 2015 Oct 15;14:90. doi: 10.1186/s12938-015-0086-5.
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006.
Hayhurst C, Byrne P, Eldridge PR, Mallucci CL Application of electromagnetic technology to neuronavigation: a revolution in image-guided neurosurgery. J Neurosurg. 2009 Dec;111(6):1179-84. doi: 10.3171/2008.12.JNS08628.
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.
