Chest discomfort Bradley et al. () Cohort study 341 patients Inclusion: Index test: Foreign-body Division of (248 patients underwent Bravo Outpatients undergoing ambulatory System: Bravo™ wireless capsule system sensation Gastroenterology monitoring) between October 2006 and Level: III-2 Insertion: transorally Chest and and Hepatology, October 2008 62% females in the wireless group, abdominal pain Quality: 15/26 Placement: 6 cm above the SCJ or 5 cm Mayo Clinic, 72% females in the catheter group Exclusion: above the upper border of the LOS Difficulty swallowing Scottsdale, CX Mean age: 58 years in wireless Known history of oesophageal strictures, Arizona, USA Painful swallowing Duration: 48 hours P2 group, 57 years in catheter group obstructions or surgical manipulations of Eating and drinking Comparator (MII-pH): the upper GI tract (e.g. anti-reflux surgery Nausea and or oesophagectomy) System: Sandhill Scientific Inc., Highland vomiting Ranch, USA Insertion: transnasally Placement: proximal channel 5 cm above upper border of the LOS Duration: 24 hours Comparator (pH-metry): System: Alpine Biomed, Corp, Fountain Valley, USA Insertion: transnasally Placement: 5 cm above the upper border of the LOS Duration: 24 hours Oesophageal Cabrera et al. () Prospective case 289 patients Inclusion: Index test: mucosa tear series Division of (At least 1 day of data was obtained Children who are at least 4 years of age System: Bravo™ wireless capsule system Pediatric in 278 patients; 2 days were obtained and weigh at least 30 lb Insertion: transorally Gastroenterology, in 274 patients) Level: IV Exclusion: Placement: at 87% of the distance from the Hepatology and 144 females, 145 males Children with a history of oesophageal Quality: Q1 incisors to the Z line Nutrition, Indiana Age: range 4–22 years surgery, a documented anatomic University School CX (no Duration: 48 hours abnormality, or a history of coagulopathy of Medicine, comparator) Indications: Comparator: NA or a bleeding diathesis Indianapolis,
Bradley et al. () Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA Cohort study Level: III-2 Quality: 15/26 CX P2 341 patients (248 patients underwent Bravo monitoring) 62% females in the wireless group, 72% females in the catheter group Mean age: 58 years in wireless group, 57 years in catheter group Inclusion: Outpatients undergoing ambulatory between October 2006 and October 2008 Exclusion: Known history of oesophageal strictures, obstructions or surgical manipulations of the upper GI tract (e.g. anti-reflux surgery or oesophagectomy) Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ or 5 cm above the upper border of the LOS Duration: 48 hours Comparator (MII-pH): System: Sandhill Scientific Inc., Highland Ranch, USA Insertion: transnasally Placement: proximal channel 5 cm above upper border of the LOS Duration: 24 hours Comparator (pH-metry): System: Alpine Biomed, Corp, Fountain Valley, USA Insertion: transnasally Placement: 5 cm above the upper border of the LOS Duration: 24 hours Chest discomfort Foreign-body sensation Chest and abdominal pain Difficulty swallowing Painful swallowing Eating and drinking Nausea and vomiting Cabrera et al. () Division of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, Indianapolis, Prospective case series Level: IV Quality: Q1 CX (no comparator) 289 patients (At least 1 day of data was obtained in 278 patients; 2 days were obtained in 274 patients) 144 females, 145 males Age: range 4–22 years Indications: Inclusion: Children who are at least 4 years of age and weigh at least 30 lb Exclusion: Children with a history of oesophageal surgery, a documented anatomic abnormality, or a history of coagulopathy or a bleeding diathesis Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: at 87% of the distance from the incisors to the Z line Duration: 48 hours Comparator: NA Oesophageal mucosa tear
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx