| ECRI (2024) | Clinical evidence assessments for EndoFLIP and Gastric Alimetry concluded available studies are limited/very-low quality; insufficient direct clinical utility evidence that testing improves patient outcomes; additional larger validation studies needed. |
| Hayes (2019/2022/2024) | Evidence analyses/HTAs found insufficient high-quality RCTs and limited support for clinical utility of EndoFLIP and MiVu MI testing; recommended continued monitoring and further research. |
| Systematic reviews (MRI defecography) | Meta-analyses conclude MRI defecography is not superior to fluoroscopic/evacuation proctography for many outcomes; sensitivity depends on inclusion of evacuation phase; does not replace reference standard but may serve as a triage test. |
| Peralta-Palmezano et al. (2024) | Systematic review/meta-analysis of EGG in gastroparesis (31 studies, 1545 patients) found altered gastric slow waves in gastroparesis versus controls (less normogastria, more bradygastria/tachygastria) but heterogeneity and protocol differences limit conclusions; clinical utility not shown. |
| Wang et al. (2024) | Exploratory comparison (n=75) found BSGM spectral analysis detected motility abnormalities at 33.3% vs GET 22.7%; BSGM phenotypes correlated better with symptom indices and psychometrics than GET; study did not demonstrate improved patient outcomes. |
| Schamberg et al. (2023) | Multicenter retrospective study (n=178) showed BSGM had substantially improved symptom correlations and higher patient-level classification accuracy versus EGG (BSGM accuracy 0.78 vs EGG 0.54 for patients vs controls; vs blinded panel 0.96 vs 0.43); limitations include retrospective design and heterogeneity. |
| Xu et al. (2024/2023) | Small cohort studies using BSGM reported correlations between gastric myoelectrical abnormalities and symptoms in post-fundoplication patients and longstanding T1D; sample sizes small and clinical utility (impact on outcomes) not demonstrated. |
| Patel 2019 / Choksi 2018 | Balloon mucosal impedance (MI) studies differentiated GERD, EoE, and non-GERD in small prospective/retrospective cohorts with distinct MI patterns, but studies limited by small size, lack of broad validation, and no demonstrated impact on clinical outcomes. |
| Hayes / ECRI reviews (BSGM, MI, EndoFLIP) | Independent review organizations summarize limited, low-quality evidence across device types (EndoFLIP, Gastric Alimetry, MiVu); recommend more robust studies and note lack of established clinical utility to change management or improve outcomes. |
| Systematic reviews / meta-analyses cited in policy (various) | Multiple systematic reviews/meta-analyses identify methodological heterogeneity, small studies, and inconsistent protocols across EGG/BSGM and MRI defecography literature, resulting in insufficient evidence to establish routine clinical use or superiority over reference standards. |
| Policy summary / Evidence-based conclusions | Overall policy conclusion: EGG/BSGM, MRI defecography, MI testing, and FLIP are considered unproven or not medically necessary for routine use due to insufficient evidence of clinical utility despite some promising diagnostic/phenotyping signals in small studies. |