Gómez V, Woodman G, Abu Dayyeh BK Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.
Mathus-Vliegen EM, Tytgat GN Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc. 2005 Jan;61(1):19-27.
Mathus-Vliegen EM Intragastric balloon treatment for obesity: what does it really offer? Dig Dis. 2008;26(1):40-4. doi: 10.1159/000109385. Epub 2008 Feb 15. Review.
Totté E, Hendrickx L, Pauwels M, Van Hee R Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg. 2001 Aug;11(4):519-23.
Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
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.
