First-in-Human Side-to-Side Duodenoileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System
Bibliographic record
Abstract
BACKGROUND: Anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The biofragmentable magnetic anastomosis system (BMAS) is endolaparoscopically placed to effect magnetic duodenoileostomy (MagDI) bipartition for reduction of weight and type 2 diabetes (T2D). MagDI obviates major risks associated with enterotomy, stapling or suturing, and retained foreign materials. STUDY DESIGN: This was a first-in-human prospective investigation of feasibility, safety, and efficacy in adults with BMI 30.0 or more to 35.0 or less kg/m 2 . An initial BMAS magnet, swallowed by the patient or delivered under anesthesia by endoscopy, was guided laparoscopically to the distal ileum; a second magnet was endoscopically positioned in the postpyloric duodenum; magnets were aligned to fuse for 7 to 21 days forming the duodenoileostomy. Primary endpoints are feasibility and severe adverse event (AE) incidence by Clavien-Dindo grade. Secondary endpoints are weight and T2D reduction. RESULTS: Between December 20, 2022, and May 21, 2024, 15 patients (mean BMI 33.0 ± 0.4 kg/m 2 ), all with T2D (glycosylated hemoglobin 8.2% ± 0.4%, glucose 187.9 ± 15.5 mg/dL, on T2D medications) underwent MagDI. The mean operative time was 51.3 ± 5.3 minutes. Feasibility at 90 days was confirmed in 100.0% with 0.0% leakage, bleeding, infection, stricture, and mortality; 89.4% of AEs were mild; and 3 Clavien-Dindo-III severe AEs were resolved. At 1 year, 100.0% of anastomoses were patent, BMI was (8) 30.1 ± 0.9 kg/m 2 , excess weight loss was 38.8%, glycosylated hemoglobin was 6.6% ± 0.1%, and glucose was 142.8 ± 9.5 mg/dL. CONCLUSIONS: The novel swallowable, BMAS was feasible, safe, and effective in achieving incisionless, suture- or staple-free magDI. The device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2D mitigation.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".