The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial

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.

Conditions

• Obesity, Morbid

Interventions

DEVICE

Endobar Infusion Catheter System

Bariatric embolization with microspheres using Endobar Infusion Catheter System

BEHAVIORAL

Behavioral therapy

Healthy diet and exercise

Sponsors & Collaborators

• OB KLINIKA a.s. Pod Krejcárkem 975 Praha 3 - Žižkov Tel.: +420 255 725 110

  collaborator UNKNOWN

• Na Homolce Hospital

  collaborator OTHER

• High Tech Med Consult

  collaborator INDUSTRY

• Endobar Solutions LLC

  lead INDUSTRY

Principal Investigators

• Martin Fried, MD · OB klinika a.s., Prague, Czech Republic

• Peter Neuzil, MD · Na Homolce Hospital, Prague, Czech Republic

• Vivek Reddy, MD · Mount Sinai Medical Center, New York, NY, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

66 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-08

Primary Completion

2018-12-01

Completion

2018-12-01

FDA Device

Yes

Countries

• Czechia