Ovesco StentFix for the Fixation of Fully Covered Self-Expanding Metal Stents and Lumen-Apposing Metal Stents Across Diverse Gastrointestinal Indications: A Single-Centre Pilot Case Series.

Background and aim Stent migration is a recognised complication of fully covered self-expandable metal stents (FCSEMS). Over-the-scope (OTS) clip-based fixation devices have emerged to address this limitation, yet real-world evidence across heterogeneous clinical indications, including lumen-apposing metal stents (LAMS) and endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures, remains limited. We report our single-centre experience with the Ovesco StentFix system (Ovesco Endoscopy AG, Tübingen, Germany) across a broad range of gastrointestinal applications. Methods This retrospective single-centre case series included consecutive patients who underwent FCSEMS or LAMS fixation using the Ovesco StentFix OTS clip system at a tertiary referral centre between January 2023 and December 2025. Both benign and malignant indications were included; EDGE procedures were analysed as a distinct subgroup. The primary outcome was stent migration. Secondary outcomes included technical success, clinical success, and adverse events. Results Twelve patients were enrolled (median age 59 years; 58.3% male). Indications comprised benign FCSEMS applications (anastomotic leak, oesophageal perforation, post-endoscopic submucosal dissection (ESD) stricture prophylaxis, and benign stricture; n=6), malignant oesophageal obstruction (n=3), and EDGE procedures (n=3). Technical success was achieved in all patients (12/12; 100%), and clinical success was achieved in 11 of 12 patients (91.7%). Stent migration occurred in four of 12 patients (33.3%), with migration observed in two of three patients with malignant obstruction (66.7%) and two of six patients with benign indications (33.3%). No migration was observed in the EDGE subgroup. One device-related adverse event occurred in a patient whose StentFix clip became deeply embedded within the oesophageal wall and could not be retrieved at stent removal (1/12; 8.3%). Two stent-related adverse events were observed. No procedure-related mortality was recorded. Conclusions The Ovesco StentFix system demonstrated universal technical success across heterogeneous gastrointestinal indications, including FCSEMS for benign and malignant conditions and LAMS fixation during EDGE procedures. The overall migration rate in this small real-world cohort exceeded that of more selected published series, likely reflecting the high-risk and mixed-indication nature of the population studied. The finding of a deeply embedded clip at stent retrieval represents an important safety observation warranting further characterisation. Larger prospective studies are required to better define optimal indications and comparative effectiveness of dedicated stent fixation devices.