Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
Brief Summary: This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.


Options:
A: Arm Label: Treatment group; Type: ACTIVE_COMPARATOR; Interventions: Device: placement of g-Cath EZ suture anchors, Behavioral: Diet and Exercise | Arm Label: Sham Group; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham procedure, Behavioral: Diet and Exercise | Intervention Type: DEVICE; Name: placement of g-Cath EZ suture anchors; Assigned to Arm(s): Treatment group | Intervention Type: PROCEDURE; Name: Sham procedure; Assigned to Arm(s): Sham Group | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Sham Group, Treatment group
B: Arm Label: Stapleless one anastomosis gastric bypass; Type: EXPERIMENTAL; Interventions: Procedure: Laparoscopic one anastomosis gastric bypass | Arm Label: Staple use mini-gastric bypass; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Laparoscopic one anastomosis gastric bypass | Arm Label: Hypocaloric diet therapy; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Hypocaloric diet therapy | Intervention Type: PROCEDURE; Name: Laparoscopic one anastomosis gastric bypass; Assigned to Arm(s): Staple use mini-gastric bypass, Stapleless one anastomosis gastric bypass | Intervention Type: DIETARY_SUPPLEMENT; Name: Hypocaloric diet therapy; Assigned to Arm(s): Hypocaloric diet therapy
C: Arm Label: Laparoscopic adjustable gastric band; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic adjustable gastric band, Behavioral: Combined life style interventions | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Combined life style interventions | Intervention Type: PROCEDURE; Name: laparoscopic adjustable gastric band; Assigned to Arm(s): Laparoscopic adjustable gastric band | Intervention Type: BEHAVIORAL; Name: Combined life style interventions; Assigned to Arm(s): Control group, Laparoscopic adjustable gastric band
D: Arm Label: g-Cath EZ Treatment Group; Type: EXPERIMENTAL; Interventions: Device: g-CathTM EZ Suture Anchor Delivery Catheter | Arm Label: Diet and exercise Control Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Diet and Exercise Control Group | Intervention Type: DEVICE; Name: g-CathTM EZ Suture Anchor Delivery Catheter; Assigned to Arm(s): g-Cath EZ Treatment Group | Intervention Type: OTHER; Name: Diet and Exercise Control Group; Assigned to Arm(s): Diet and exercise Control Group

Answer: A