P2 responsive to twice-daily PPI therapy for a minimum of 6 weeks Overall discomfort Gillies et al. () Non-randomised 185 patients, but 200 oesophageal Inclusion: Index test: (during insertion controlled trial pH studies Departments of See indication System: Bravo™ wireless capsule system and monitoring) Upper 104 males, 81 females Insertion: transorally Nasal discomfort Gastrointestinal Level: III-2 Mean age: Throat discomfort Exclusion: Placement: 6 cm proximal to the SCJ Surgery and Quality: 13.5/26 Catheter group: 46 years (range Oesophageal Gastrointestinal No specific exclusion criteria exist Duration: 48 hours discomfort Physiology, Royal CX Comparator: Berkshire Interference with Bravo group: 45 years (range 13–75) P2 hospital, daily activities System: Medtronic Indication: Reading, UK Eating Insertion: transnasally Symptoms suggestive of GORD or Sleeping Placement: 5 cm above the proximal border documenting the outcome of Work attendance of the LOS laparoscopic anti-reflux surgery Duration: 24 hours Discomfort at Grigolon et al. () 133 patients Inclusion: Index test: placement Gastroenterology, Catheter group: 78 patients, 46% See indication System: Bravo™ wireless capsule system Overall discomfort controlled trial Department of males, aged 53 ± 2 years Exclusion: Insertion: transorally Chest discomfort Medical Bravo group: 55 patients, 45% males, Previous GI surgery (excluding Placement: 6 cm above the SCJ Eating and drinking Sciences, Level: III-1 aged 44 ± 3 years) cholecystectomy and appendectomy) and University of Interference with Duration: 48 hours Quality: 13.5/26 Indication: known or suspected stricture of the GI Milan, Milan, Italy daily activities Comparator: tract CX Suspected GORD, consecutively System: Slimline mod 901P3001, referred for oesophageal pH P2 Medtronic, Denmark monitoring Insertion: transnasally Placement: 6 cm above the point of sudden change in pH from acid to neutral as detected by means of continuous rapid withdrawal from the stomach, or 5 cm above the upper margin of the LOS
P2 responsive to twice-daily PPI therapy for a minimum of 6 weeks Gillies et al. () Departments of Upper Gastrointestinal Surgery and Gastrointestinal Physiology, Royal Berkshire hospital, Reading, UK Non-randomised controlled trial Level: III-2 Quality: 13.5/26 CX P2 185 patients, but 200 oesophageal pH studies 104 males, 81 females Mean age: Catheter group: 46 years (range Bravo group: 45 years (range 13–75) Indication: Symptoms suggestive of GORD or documenting the outcome of laparoscopic anti-reflux surgery Inclusion: See indication Exclusion: No specific exclusion criteria exist Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm proximal to the SCJ Duration: 48 hours Comparator: System: Medtronic Insertion: transnasally Placement: 5 cm above the proximal border of the LOS Duration: 24 hours Overall discomfort (during insertion and monitoring) Nasal discomfort Throat discomfort Oesophageal discomfort Interference with daily activities Eating Sleeping Work attendance Grigolon et al. () Gastroenterology, Department of Medical Sciences, University of Milan, Milan, Italy controlled trial Level: III-1 Quality: 13.5/26 CX P2 133 patients Catheter group: 78 patients, 46% males, aged 53 ± 2 years Bravo group: 55 patients, 45% males, aged 44 ± 3 years) Indication: Suspected GORD, consecutively referred for oesophageal pH monitoring Inclusion: See indication Exclusion: Previous GI surgery (excluding cholecystectomy and appendectomy) and known or suspected stricture of the GI tract Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ Duration: 48 hours Comparator: System: Slimline mod 901P3001, Medtronic, Denmark Insertion: transnasally Placement: 6 cm above the point of sudden change in pH from acid to neutral as detected by means of continuous rapid withdrawal from the stomach, or 5 cm above the upper margin of the LOS Discomfort at placement Overall discomfort Chest discomfort Eating and drinking Interference with daily activities
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx