The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of the Endobar gastric embolization system for the
      treatment of obesity before continuing to a larger Pivotal Trial.

      Investigational Device The investigational device in this clinical study is the Endobar
      Infusion Catheter System - a disposable system consisting of an occlusion balloon catheter, a
      Smart Manifold delivery system.

      Study Design/Planned Number of Subjects This study is a prospective, sham controlled,
      single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and
      women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study.
      Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham
      procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left
      gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive
      Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects
      randomized to the Sham Control group will receive catheter-based embolization of the left
      gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups
      will be followed for a total of 12 months.

      Study Duration The duration of the study is expected to last approximately 18 months from the
      first enrollment . An additional 12 months to the study closeout after the last follow-up.
    

Detailed description: 
      STUDY OBJECTIVES Objective The objective of this study is to conduct a sham controlled
      randomized trial to evaluate the efficacy and safety of the Endobar System for the treatment
      of obesity. Efficacy, Safety, and secondary outcomes will be evaluated at 6 and 12 months to
      allow expansion of the investigation into a larger, pivotal clinical study.

      Study Design This is a prospective randomized, single blind, active treatment and sham
      controlled, single-center trial . After the informed consent and screening process are
      completed, all subjects who are eligible and wish to participate in the study will undergo
      baseline testing. Those who complete baseline testing will be randomized to either Endobar
      Therapy (ET) or Sham Treatment (ST) for 52 weeks. Both groups will be given lifestyle therapy
      for weight loss, which involves treatment with a behavioral education weight loss program
      delivered as 19 individual sessions in person over 52 weeks. Endobar Therapy involves
      catheter-based embolization of the left gastric artery. After 26 weeks, the ET group will
      continue to be monitored for an addition 26 weeks and the ST subjects will be given ET and
      monitored for 26 weeks. The duration of the entire study will be 52 weeks.
    

Intervention name(s): Endobar Infusion Catheter System; Behavioral therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Bariatric embolization with microspheres using Endobar Infusion Catheter System; Healthy diet and exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Embolization; Left Gastric Artery