procedure, previous failed pH test Wenner, Johnsson Randomised 35 patients (31 patients had Inclusion: Index test: Technical efficacy: et al. () crossover trial enough data to be included) Patients referred for oesophageal pH System: Bravo™ wireless capsule system Technical problems 15 males, 16 females monitoring Department of Insertion: transorally Surgery, Lund Level: II Median age: 52 years Exclusion: Placement: 6 cm above the SCJ University Hospital, Quality: 20/26 Median BMI: 27 (range 24–28) Patients with coagulopathy, severe Duration: 48 hours Lund, Sweden oesophagitis/stricture, portal CX Indications: Comparator: hypertension, a pacemaker, age <20 or P2 Typical reflux symptoms (55%) System: Slimline (Medtronic) >70 years, previous and atypical reflux symptoms Insertion: transnasally surgery, severe (45%) Placement: 5 cm above the upper border of cardiopulmonary disease, symptoms the LOS suggestive of oesophageal motor disorders Duration: 24 hours Wenner et al. (); Case-control 70 patients, but 64 had enough Inclusion: Index test: Technical efficacy: Wenner. study data to be included (39 males, Patients: presence of typical reflux System: Bravo™ wireless capsule system Early detachment Johansson et al. () 25 females) and 55 controls Level: IV symptoms such as heartburn and Insertion: transorally Capsule unable to pass (27 males and 28 females) regurgitation. Symptoms had to occur Department of Quality: Q2 through oesophagus Placement: 6 cm above the SCJ Not all patients are included in more than twice weekly. Treatment with Surgery, Lund CX Transmission failure / the distal capsule outcomes medical acid suppression had to result University Hospital, loss of signal P3 in complete symptom relief or a more Lund, Sweden Indications: Incorrect capsule than 50% reduction of the symptoms Patients with typical reflux placement Exclusion: symptoms Coagulopathy, severe oesophagitis/stricture, portal hypertension, pacemaker, <20 or >70 years of age, history of surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders
procedure, previous failed pH test Wenner, Johnsson et al. () Department of Surgery, Lund University Hospital, Lund, Sweden Randomised crossover trial Level: II Quality: 20/26 CX P2 35 patients (31 patients had enough data to be included) 15 males, 16 females Median age: 52 years Median BMI: 27 (range 24–28) Indications: Typical reflux symptoms (55%) and atypical reflux symptoms (45%) Inclusion: Patients referred for oesophageal pH monitoring Exclusion: Patients with coagulopathy, severe oesophagitis/stricture, portal hypertension, a pacemaker, age <20 or >70 years, previous surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ Duration: 48 hours Comparator: System: Slimline (Medtronic) Insertion: transnasally Placement: 5 cm above the upper border of the LOS Duration: 24 hours Technical efficacy: Technical problems Wenner et al. (); Wenner. Johansson et al. () Department of Surgery, Lund University Hospital, Lund, Sweden Case-control study Level: IV Quality: Q2 CX P3 70 patients, but 64 had enough data to be included (39 males, 25 females) and 55 controls (27 males and 28 females) Not all patients are included in the distal capsule outcomes Indications: Patients with typical reflux symptoms Inclusion: Patients: presence of typical reflux symptoms such as heartburn and regurgitation. Symptoms had to occur more than twice weekly. Treatment with medical acid suppression had to result in complete symptom relief or a more than 50% reduction of the symptoms Exclusion: Coagulopathy, severe oesophagitis/stricture, portal hypertension, pacemaker, <20 or >70 years of age, history of surgery, severe cardiopulmonary disease, symptoms suggestive of oesophageal motor disorders Index test: System: Bravo™ wireless capsule system Insertion: transorally Placement: 6 cm above the SCJ Technical efficacy: Early detachment Capsule unable to pass through oesophagus Transmission failure / loss of signal Incorrect capsule placement
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx