Grigolon et al. One arm of matched 57 patients in the 6/57 procedures (10.5%): (2011)a pairs retrospective catheter-free group 3 incomplete data capture cohort study 3 early detachment Level: IV Quality: Q2 CX P2 Belafsky et al. Prospective case 46 patients 6/46 procedures (13.0%): (2004) series 2 failures because of tight nasal vault Level: IV 2 early detachments Quality: Q2 1 lost data recorder CX 1 capsule failed to deploy from catheter P2 Sweis et al. Case series 38 patients 0/38 procedures (0%): (2011) Level: IV 0 early detachments (detachment occurred between 48 and 72 hours in 5 patients and Quality: Q2 between 72 and 96 hours in 12 patients) CX P2 Martinez de Haro One arm of 25 patients and 10 6/35 procedures (17.1%) et al. (2008)a controlled volunteers 3 incorrect placements trial 2 early detachments Level: IV 1 immediate detachment with aspiration Quality: Q2 CX P2 Bechtold et al. Retrospective case 27 patients 1/27 procedures (3.7%): (2007) series 1 early detachment Level: IV Quality: Q2 CX P2 Francis et al. Randomised 22 patients 0/22 procedures (0%): (2012)a controlled trial All capsules were placed successfully on the first Level: IV attempt Quality: Q2 C1 P2 Pandolfino et al. Case-control study 10 patients and 10 2/20 procedures (10%): (2006)a volunteers Level: IV 2 early detachments Quality: Q2 CX (clinical diagnosis) P3 Sofi et al. (2011) Retrospective case 58 patients 5/58 procedures (8.6%): series 2 malfunctions of the device during insertion Level: IV 3 transmission failures Quality: Q3 CX P2
Grigolon et al. (2011)a One arm of matched pairs retrospective cohort study Level: IV Quality: Q2 CX P2 57 patients in the catheter-free group 6/57 procedures (10.5%): 3 incomplete data capture 3 early detachment Belafsky et al. (2004) Prospective case series Level: IV Quality: Q2 CX P2 46 patients 6/46 procedures (13.0%): 2 failures because of tight nasal vault 2 early detachments 1 lost data recorder 1 capsule failed to deploy from catheter Sweis et al. (2011) Case series Level: IV Quality: Q2 CX P2 38 patients 0/38 procedures (0%): 0 early detachments (detachment occurred between 48 and 72 hours in 5 patients and between 72 and 96 hours in 12 patients) Martinez de Haro et al. (2008)a One arm of controlled trial Level: IV Quality: Q2 CX P2 25 patients and 10 volunteers 6/35 procedures (17.1%) 3 incorrect placements 2 early detachments 1 immediate detachment with aspiration Bechtold et al. (2007) Retrospective case series Level: IV Quality: Q2 CX P2 27 patients 1/27 procedures (3.7%): 1 early detachment Francis et al. (2012)a Randomised controlled trial Level: IV Quality: Q2 C1 P2 22 patients 0/22 procedures (0%): All capsules were placed successfully on the first attempt Pandolfino et al. (2006)a Case-control study Level: IV Quality: Q2 CX (clinical diagnosis) P3 10 patients and 10 volunteers 2/20 procedures (10%): 2 early detachments Sofi et al. (2011) Retrospective case series Level: IV Quality: Q3 CX P2 58 patients 5/58 procedures (8.6%): 2 malfunctions of the device during insertion 3 transmission failures
1203-ContractedAssessmentReport-Catheter-free%20ambulatory%20pH%20test%20for%20GORD%20accessible.docx