| Eligibility |
Inclusion Criteria:
1. 18-65 years of age, inclusive, at the time of informed consent
2. BMI 30-35 kg/m2
3. Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve
gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that
would affect body weight for the duration of the study
5. If a child-bearing female, subject must commit to not becoming pregnant and agree to
use contraception for the duration of the study
6. Willing and able to comply with protocol requirements
Exclusion Criteria:
1. Type 1 diabetes
2. Use of injectable insulin
3. Uncontrolled T2DM
4. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the
duodeno-ileal anastomosis 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 or
contra-indicate 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, and
manipulation techniques.
14. Implantable pacemaker or defibrillator
15. Psychiatric disorder, except well-controlled depression with medication for > 6 mo
16. History of substance abuse
17. Woman who is either pregnant or breast feeding
18. Woman of childbearing potential who does not agree to use an effective method of
contraception.
19. Any comorbidity or current status of subject's physiological fitness that in the
surgeon's or anesthesiologist's opinion represents safety concerns that make the
subject medically unfit for the procedure.
20. Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic
procedures
21. Had surgical or interventional procedure within 30 days prior to procedure
22. Any scheduled surgical or interventional procedure planned within 30 days
post-procedure
23. Any stroke/transient ischemic attack (TIA) within 6 months prior to consent
24. Requires chronic anticoagulation therapy (except aspirin)
25. Active infections requiring antibiotic therapy, unless resolved before undergoing the
study procedure
26. Unable to comply with the follow-up schedule and assessments
27. Recent tobacco or nicotine product cessation within < 3 months prior to informed
consent
28. Known allergies to the device components or contrast media
29. Limited life expectancy due to terminal disease
30. Currently participating in another clinical research study with an investigational
drug or medical device
31. A positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19)
test prior to the study procedure in accordance with local COVID-19 protocol
32. Any condition that, in the investigator's opinion, may preclude completion of
follow-up assessments through Day 360 (e.g., a medical condition that may increase the
risk associated with study participation or may interfere with interpretation of study
results, inability to adhere to the visit schedule, or poor compliance with treatment
regimen)
|
