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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Bariatric embolization with microspheres using Endobar Infusion Catheter System
Healthy diet and exercise
OB klinika a.s., Pod Krejcárkem 975
Praha 3 - Žižkov, Czechia
Weight Loss
1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference. 2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).
Time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Adverse Events
The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.
Time frame: 12 months post-randomization
Absolute Weight Loss (kg)
6-month change: The absolute difference in the initial and 6-month weight (kg) (i.e., initial - 6 month weight). These changes were averaged for each group and compared between the two groups to assess whether there was a meaningful difference. 12-month change: The absolute difference in the initial and 12-month weight (kg) (i.e., initial - 12 month weight).
Time frame: 6 months post-procedure/sham and 12 months post-procedure
Percent Excess Body Weight (%EBWL) Loss
Percent excess body weight loss (% EBWL) is calculated by dividing the absolute weight loss divided by baseline excess weight and multiplying by 100% (i.e., excess weight / initial weight x 100%). Excess weight is defined as the difference between current weight and ideal weight. %EBWL was calculated for the following time points: 1. 6 months: absolute weight loss was the difference from baseline to 6 months. %EBWL was averaged for each group and compared to assess whether there was a meaningful difference between the groups. 2. 12 months: absolute weight loss was the difference from baseline to 12 months. Note, excess weight was determined from ideal body weights based on a BMI=25 kg/m2.
Time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Weight Loss ≥5%
Proportion of subjects who achieve ≥5% total body weight loss from baseline vs. those who do not
Time frame: 6 months post-procedure/sham
6 Month Change in Lipids
6-month change (from baseline) in lipids for both groups. Unit of Measure: mg/dL
Time frame: 6 months post-procedure/sham
6 and 12 Month Change in Blood Pressure
Change in absolute blood pressure levels from baseline to 6 months for both groups and baseline to 12 months for the initial treatment group. Unit of Measure: mmHg
Time frame: 6 months post-procedure/sham and 12 months post-procedure
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