Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
Brief Summary: The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.

It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.

The primary efficacy endpoint is:

* Assessment of the difference in % excess weight loss between the 2 groups

Secondary endpoints are:

* Resolution or Improvement in type II Diabetic status as defined as:
* Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
* Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
* The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.


Options:
A: Arm Label: EndoBarrier Device; Type: EXPERIMENTAL; Interventions: Device: EndoBarrier Device, Behavioral: Diet & Lifestyle Counseling | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diet & Lifestyle Counseling | Intervention Type: DEVICE; Name: EndoBarrier Device; Assigned to Arm(s): EndoBarrier Device | Intervention Type: BEHAVIORAL; Name: Diet & Lifestyle Counseling; Assigned to Arm(s): Control, EndoBarrier Device
B: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: gastric bypass | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Procedure: sleeve gastrectomy | Intervention Type: PROCEDURE; Name: gastric bypass; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: sleeve gastrectomy; Assigned to Arm(s): 3
C: Arm Label: Bariatric surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Bariatric surgery | Arm Label: Intensive lifestyle intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle intervention | Intervention Type: PROCEDURE; Name: Bariatric surgery; Assigned to Arm(s): Bariatric surgery | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle intervention; Assigned to Arm(s): Intensive lifestyle intervention
D: Arm Label: GBP; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Bariatric surgery: Gastric bypass | Arm Label: BPD 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Bariatric surgery: Bilio-pancreatic diversion | Arm Label: Med Ter3; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: anti-diabetic drugs and behavioral suggestions | Intervention Type: PROCEDURE; Name: Bariatric surgery: Gastric bypass; Assigned to Arm(s): GBP | Intervention Type: PROCEDURE; Name: Bariatric surgery: Bilio-pancreatic diversion; Assigned to Arm(s): BPD 2 | Intervention Type: BEHAVIORAL; Name: anti-diabetic drugs and behavioral suggestions; Assigned to Arm(s): Med Ter3

Answer: A