Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial.

Background/objectives: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.

Subjects/methods: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone.

Computer-Assisted and Patient-Controlled Sedation Platforms.

As the number and complexity of endoscopic procedures increase, the role of sedation has been integral in patient and physician satisfaction. This article discusses the advances of computer-assisted and patient-controlled platforms. These computer-assisted and patient-controlled platforms use different anesthetics and analgesics, all with the intent of achieving improved consistency in the level of sedation, appropriate to the needs of patients, while also improving patient safety.

A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy.

Background: This exploratory study was the first study of remimazolam in patients to assess the safety and efficacy of different single doses for procedural sedation.

Methods: Patients scheduled to undergo a diagnostic upper gastrointestinal endoscopy were randomized to receive 1 of 3 doses of remimazolam or midazolam (25 per group) in a double-blind manner. After a single dose of study drug to achieve sedation, patients underwent gastroscopy.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products.

Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study.

Background: The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely administer propofol.

Objective: To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures.

Design: Nonblinded multicenter randomized comparative study.

Future directions in endoscopic sedation.

The role of sedation in endoscopic procedures has increased and so has the demand for advances in its administration. The pursuit of new agents or administration techniques and their study specific to endoscopic nonsurgical procedures is necessary to improve patient comfort and safety.The science of moderate and deep sedation specific to endoscopy is fledgling but approaching new horizons.

An assessment of computer-assisted personalized sedation: a sedation delivery system to administer propofol for gastrointestinal endoscopy.

Background: Demand for colonoscopy and EGD procedures is increasing. Impediments to performing these examinations persist. Patients perceive these procedures as unpleasant and painful.

Open-label, dose-ranging pilot study of 4 weeks of low-dose therapy with sodium phosphate tablets in chronically constipated adults.

Background: The tablet formulation of sodium phosphate (NaP) is a prescription osmotic purgative that has been marketed since 2001. The use of NaP tablets in patients with constipation has not been studied previously.

Objective: This study assessed the tolerability and efficacy of 28 days of therapy with NaP tablets (1.

Low volume bowel preparation for colonoscopy: randomized, endoscopist-blinded trial of liquid sodium phosphate versus tablet sodium phosphate.

Objective: The aim of this study was to compare the colon-cleansing effectiveness, ease of consumption, and side effect profiles of two commercially available preparations of sodium phosphate: liquid Fleet Phospho-soda and Visicol tablets.

Methods: Outpatients undergoing elective colonoscopy were sequentially randomized to one of two preparation groups: liquid: 45 ml at 7:00 PM, 45 ml 3 h before colonoscopy; or tablet: 20 tablets at 7:00 PM, 20 tablets 3-5 h before colonoscopy. Subjects rated preparation tolerability on a 5-point Likert scale.

Microdose 14C-urea breath test offers diagnosis of Helicobacter pylori in 10 minutes.

Objectives: The urea breath test diagnoses Helicobacter pylori infection of the stomach by identifying the urease enzyme activity of the bacterium. In this "microdose" version of the test, 1 microCi 14C-urea is given orally in a capsule. Our objectives were: 1) to evaluate a microdose 14C-urea breath test capsule in a gastroenterology outpatient setting, 2) to determine the diagnostic ranges of the 14C-urea breath test for HP-positive and HP-negative patients, 3) to define the sensitivity and specificity of the test, and 4) to see whether breath sample results changed when they were mailed to a remote site for analysis.

Human sphincter of Oddi motility and cholecystokinin response following liver transplantation.

The reported incidence of sphincter of Oddi dysfunction following orthotopic liver transplantation has ranged from 3% to 7%. If sphincteric dysfunction is unrecognized, therapy may be inappropriate; when recognized, extensive surgery may be required. To prospectively identify patients with sphincteric dysfunction, we performed sphincter of Oddi motility studies through the t-tube tract three months after transplantation.

Campylobacter pylori colonizing heterotopic gastric tissue in the rectum.

Campylobacter pylori specifically attaches to gastric epithelial cells and is the etiologic agent for type B gastritis. The authors report the case of a woman with the rare finding of heterotopic gastric mucosa in the rectum that was colonized with C. pylori.