GERD — Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer
Citation(s)
Eastone, J A., Horwhat, D., Haluska, O., Mathews, J., & Johnston, M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] [Electronic version]. Gastrointestinal Endoscopy 53: A3448, 2001.
Johnston MH Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.
Johnston, M , Horwhat, J., Dubois, A., & Schoenfeld, P. Endoscopic cryotherapy in the swine esophagus: A follow-up study [Abstract]. Gastrointestinal Endoscopy 49: AB126, 1999.
Johnston, M H. Endoscopic cryotherapy: A new ice age in gastroenterology? [Electronic version]. Medscape Gastroenterology 2:(4)2000.
Johnston, M H., Eastone, J.A., & Horwhat, J.D. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98: (9,Suppl), A30,S11, 2003.
Johnston, M H., Horwhat, J.D., Haluska, O., & Moses, F.M. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model [Abstract] [Electronic version]. Gastrointestinal Endoscopy 51: AB98,3462, 2000.
Johnston, M H., Schoenfeld, P., Mysore, J., Kita, J.A., & Dubois, A. Endoscopic cryotherapy: A new technique for tissue ablation in the esophagus [Abstract]. American Journal of Gastroenterology 92: A44, 1997.
Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer
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.
