| Werner et al. 2019 (RCT POEM vs LHM+fundoplication) | 2-year clinical success: POEM 83.0% vs LHM 81.7%; POEM non-inferior (noted higher post‑procedure reflux). |
| Martinek et al. 2022 (G-POEM randomized sham‑controlled) | At 6 months: clinical success 15/21 G-POEM vs 4/20 sham; 10 serious adverse events (3 related to G‑POEM). |
| Zerbib et al. 2020 (Stretta RCT, double‑blind sham) | No significant difference vs sham at 24 and 48 weeks for symptoms or PPI use; did not demonstrate efficacy over sham. |
| Enterra Therapy System (FDA HDE, 2000) | HDE approved for chronic intractable (drug‑refractory) nausea and vomiting secondary to diabetic or idiopathic gastroparesis in ages 18–70; labeling lists contraindications. |
| ECRI assessments (GES, G‑POEM, Stretta, LINX, EsophyX) | Conclude potential benefits but very low/insufficient quality evidence; call for larger RCTs and longer‑term outcomes (updated reviews noted). |
| ACG guideline Katz 2021 (GERD) and ACG gastroparesis guidance | Recommend consideration of MSA as alternative to fundoplication for regurgitation; ACG suggests GES may be considered as HUD for refractory diabetic/idiopathic gastroparesis (conditional, low quality). |
| MSA/LINX systematic reviews and RCTs (e.g., Bell 2019/2020, Fadel 2024, Valinoti 2024) | Multiple studies show symptom control, high PPI cessation rates and patient satisfaction; complications include dysphagia, dilation, and device explantation/erosion; long‑term comparative data limited. |
| Mandarino 2024 (G‑POEM systematic review/meta‑analysis) | Pooled ~70% clinical success at 1 year (n=952); evidence weak with variable definitions and limited long‑term data. |
| Stojilkovic et al. 2023 / other G‑POEM series (safety/long‑term) | Observational series report sustained symptom improvement in many patients but heterogeneity, inconsistent definitions, and limited long‑term durability data. |
| Kalapala et al. 2022 (EFTP RCT) | 65.7% achieved ≥50% GERD‑HRQL improvement vs 2.9% sham at 12 months; suggests benefit for endoscopic full‑thickness fundoplication in selected patients. |
| POEM systematic reviews/meta‑analyses (e.g., Khan 2017, North & Tewari 2024) | High clinical success for achalasia and spastic esophageal disorders (WPR ≈ 87% overall); POEM considered effective and non‑inferior to LHM in RCTs but with higher reflux risk. |
| Mandarino / Stojilkovic / Martinek group evidence summarized (G‑POEM) | RCT evidence limited but some RCT shows superiority to sham; overall evidence judged insufficient/very low quality and further RCTs needed. |
| Selected G‑POEM safety series (Baret 2022, Chung 2022) | Procedure generally safe in experienced centers; reported adverse events include bleeding, mucosal injury, abscess, dumping; serious AE rates low but present. |
| Hayes HTA and other HTAs on GES and Stretta | Hayes concluded GES effectiveness uncertain with low‑quality evidence and device removal rates 7–12%; Stretta HTA found low‑quality evidence with potential but unproven benefit. |
| GERDx/MUSE and other endoscopic GERD device summaries (FDA clearances noted) | Various devices received FDA 510(k)/PMA (EsophyX, MUSE, GERDx submitted 510(k)), studies show short‑term symptom/QOL improvements but durability and comparative effectiveness remain uncertain. |