ESSENTIAL Trial™ Sham Cross-over
Condition: Obesity
Study type: Interventional

Summary: 
      This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended
      to evaluate the safety and efficacy of treating previous sham subjects in the Essential
      pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture
      anchors along with diet and exercise). Compliant sham subjects (those who attended all
      primary IDE follow-up visits AND who continue to meet eligibility criteria as described in
      this protocol) will be offered this active treatment after their 12 month unblinding visit in
      the Essential pivotal trial.
    

Detailed description: 
      This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended
      to evaluate the safety and efficacy of treating previous sham subjects in the Essential
      pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture
      anchors along with diet and exercise). Compliant sham subjects (those who attended all
      primary IDE follow-up visits AND who continue to meet eligibility criteria as described in
      this protocol) will be offered this active treatment after their 12 month unblinding visit in
      the Essential pivotal trial.

      This supplemental study will consist of up to an 8 week screening period after each subject's
      unblinding visit, an enrollment (active treatment) day, and a 12-month follow-up period. All
      sham subjects in the Essential Trial (total quantity of one hundred eleven (111) subjects)
      are planned for enrollment, but the total quantity of sham subjects provided the active
      treatment will depend on the number of subjects who are compliant. The active treatment will
      be provided by the original investigator for that subject at the same investigational center
      (one of the original 11) used in the Essential trial. Collection of data will be accomplished
      by utilizing independent nutritionists/clinical research nurses to administer the
      diet/exercise plan and collect weight loss efficacy assessments. Efficacy assessments will
      also include changes in select co-morbidities, quality of life assessments, and changes in
      hunger and satiety, among others. Safety assessments include subject and investigator
      reported adverse events, physician follow-up assessments, and blood pressure measurements.
    

Intervention name(s): g-Cath EZ™ Suture Anchor Delivery Catheter
Intervention type(s): Device
Intervention description(s): This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment