Trial reportSurgical endoscopy2026
The functional lumen opening with self-forming magnetic anastomosis (FLOWS) study: results from the North American pivotal trial.
Trial report in Surgical endoscopy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and effectiveness of using self-forming magnets (SFM) with an immediately functional lumen for the creation of small bowel anastomoses.
backgroundPrevention of short-, medium-, and long-term gastrointestinal anastomotic complications remains a clinical challenge. Magnetic compression techniques with the ability to provide an immediately functional lumen may provide safer and more consistent anastomoses with reduced risk of leak, bleed, and/or stricture.
methodsThis multicenter, prospective, single-arm pivotal clinical study evaluated the Flexagon 25 mm SFM system plus OTOLoc in adult patients undergoing laparoscopic surgery requiring the creation of a small bowel anastomosis. The primary endpoint was defined as successful anastomosis created with the SFM with immediate functional lumen technique without placement procedure, device, or target anastomosis-related reoperation through 30 days. Adverse events were monitored and classified per Clavien-Dindo criteria.
resultsAcross six centers, 79 patients underwent laparoscopic small bowel anastomosis creation with an SFM that provided an immediately functional lumen. All patients achieved the primary study endpoint. There were no reported cases of small or large bowel obstruction, anastomotic bleed, leak, re-intervention, or death. The most common adverse events included abdominal pain (35 cases), nausea (21), and incision site pain (21), with only four serious adverse events. There were no serious device-related adverse events. Median (interquartile range) procedure and anastomosis creation times were 92 (76, 116) and 13 (9, 17) minutes, respectively.
conclusionThis clinical trial highlights the technical and clinical success and the short-term safety profile of an SFM system that provides an immediately functional lumen for the creation of a small bowel anastomosis. The results provide a robust platform for future controlled and comparative studies to more comprehensively define the role of magnetic compression anastomosis in gastrointestinal surgery.
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