Magnetic Duodeno-Ileal Chile Study

Inclusion Criteria:

1. Between 18-65 years of age, at the time of informed consent.

2. Body Mass Index (BMI) between 30-50 kg/m2.

3. Meets one of the following criteria:

4. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regainfollowing previous sleeve gastrectomy (≥ 12 months); OR

5. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regainfollowing previous endoscopic sleeve gastroplasty (≥ 12 months); OR

6. Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Indexbetween 30-35 and without previous sleeve gastrectomy and no plan to perform aconcurrent sleeve gastrectomy.

7. Participant agrees to refrain from any type of additional bariatric orreconstructive surgery that would affect body weight for the duration of the study.

8. Participant has been informed of the nature of the study and agrees to itsprovisions, complying with study required testing, medications, follow-up visits,and has provided written informed consent.

Exclusion Criteria:

1. Type 1 diabetes.

2. Use of injectable insulin.

3. Uncontrolled Type 2 Diabetes Mellitus (T2DM).

4. Investigator plans to perform a sleeve gastrectomy with the duodeno-ilealanastomosis procedure.

5. Uncontrolled hypertension, dyslipidemia or sleep apnea.

6. Prior intestinal, colonic or duodenal surgery (other than bariatric).

7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent orcontraindicate the procedure, including scarring and abnormal anatomy.

8. Refractory gastro-esophageal reflux disease (GERD).

9. Barrett's disease.

10. Helicobacter pylori positive and/or active ulcer disease.

11. Large hiatal hernia.

12. Inflammatory bowel or colonic diverticulitis disease.

13. Any anomaly precluding orogastric access by gastroscope and catheters, andmanipulation techniques.

14. Any anomaly preventing / contraindicating endoscopic or laparoscopic access andprocedures.

15. Implantable pacemaker or defibrillator.

16. Psychiatric disorder, except well-controlled depression with medication for > 6months.

17. History of substance abuse.

18. Pregnant, lactating, or planning pregnancy during the clinical investigation. Note:Female participants of childbearing age must agree to use safe contraception (e.g.,intrauterine devices, hormonal contraceptives: contraceptive pills, implants,transdermal patches hormonal vaginal devices, injections with prolonged release).

19. Any comorbidity or current status of participant's physiological fitness that in thesurgeon's or anesthesiologist's opinion represents safety concerns that make theparticipant medically unfit for the procedure, including any significant congenitalor acquired anomalies of the GI tract at or distal to the placement of the Magnets.

20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnetdeployment site.

21. Expected need for Magnetic Resonance Imaging (MRI) within the first 2 monthspost-procedure.

22. Any surgical or interventional procedure (including planned and/or scheduled) withinthe period of 30 days prior to and 30 days following the study procedure.

23. Any stroke/TIA ≤ 6 months prior to consent.

24. Requires chronic anticoagulation therapy (except aspirin).

25. Active infections requiring antibiotic therapy, unless resolved before undergoingthe study procedure.

26. Recent tobacco or nicotine product cessation ≤ 3 months prior to informed consent.

27. Known allergies to the device components (including the biofragmentable materialPGLA or similar compounds) or contrast media.

28. Participants with comorbidities that are likely to result in a life expectancy of ≤ 12 months.

29. Currently participating in an investigational drug or another device study that hasnot reached its primary endpoint: Note: Studies requiring extended follow-up for products that were investigational,but have since become commercially available, are not considered investigationaltrials.

30. A positive COVID-19 test prior to the study procedure in accordance with localCOVID-19 protocol.

31. Presence of other anatomic or comorbid conditions, or other medical, social orpsychological conditions that, in the investigator's opinion, could limit theparticipant's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.