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

NCT03185949 | Completed Results DMC FDA Device

• 1 other identifier: ESC-14-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Embolization; Left Gastric Artery

Outcome Measures

Primary Outcomes (3)

• 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%).

  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.

  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).

  6 months post-procedure/sham and 12 months post-procedure

Secondary Outcomes (4)

• Percent Excess Body Weight (%EBWL) Loss

  1) 6 months post-procedure/sham and 2) 12 months post-procedure

• Number of Patients With Weight Loss ≥5%

  6 months post-procedure/sham

• 6 Month Change in Lipids

  6 months post-procedure/sham

• 6 and 12 Month Change in Blood Pressure

  6 months post-procedure/sham and 12 months post-procedure

Other Outcomes (10)

• Ghrelin Levels

  [Time Frame: 6-12 months]

• Glucagon-like Peptide 1 Concentrations

  [Time Frame: 6-12 months]

• Oral Glucose Tolerance and Insulin Sensitivity

  [Time Frame: 6-12 months]

Study Arms (2)

Sedation and subcutaneous lidocaine

SHAM COMPARATOR

Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization.

Device: Endobar Infusion Catheter System; Behavioral: Behavioral therapy

interventional: bariatric embolization

EXPERIMENTAL

• In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy

Device: Endobar Infusion Catheter System; Behavioral: Behavioral therapy

Interventions

Endobar Infusion Catheter System DEVICE

Bariatric embolization with microspheres using Endobar Infusion Catheter System

Sedation and subcutaneous lidocaine; interventional: bariatric embolization

Behavioral therapy BEHAVIORAL

Healthy diet and exercise

Sedation and subcutaneous lidocaine; interventional: bariatric embolization

Eligibility Criteria

• Age: 21 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 35.0-50.0 kg/m2 at time of screening
• Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.
• Willing and able to provide informed consent

You may not qualify if:

• Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery
• History of duodenal or gastric ulcers or regularly taking medications (therapy \>1 day per week) that can cause ulcers (e.g., non-steroidal anti-inflammatory drugs)
• Prior radiation to the upper abdomen
• Prior embolization to the stomach, spleen or liver
• Portal venous hypertension
• Active H. pylori infection
• Uncontrolled hypertension (\> 160/100 with or without medication).
• Diabetes (determined by medical history, fasting blood glucose or results of an oral glucose tolerance test)
• Serum triglyceride \> 400 mg/dL at screening.
• Class 4 or 5 surgical risk based on standard ASA criteria (Saklad M. Grading of patients for surgical procedures. Anesthesiol. 1941; 2:281-4).
• Severe pulmonary or cardiovascular disease defined as a history or evidence of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome, coronary revascularization, heart failure requiring medications, history of sudden cardiac death, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
• Class III: patients with marked limitation of activity; they are comfortable only at rest.
• Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
• Coagulation disorders (platelets \< 100,000, PT \> 2 seconds above control or INR \> 1.5 at screening).
• Anemia (Hb \< 10.0 g/dL) at screening.

Sponsors & Collaborators

• Endobar Solutions LLC: lead
• OB KLINIKA a.s. Pod Krejcárkem 975 Praha 3 - Žižkov Tel.: +420 255 725 110: collaborator
• Na Homolce Hospital: collaborator
• High Tech Med Consult: collaborator

Study Sites (1)

OB klinika a.s., Pod Krejcárkem 975

Praha 3 - Žižkov, 130 00, Czechia

Location

Related Publications (1)

• Reddy VY, Neuzil P, Musikantow D, Sramkova P, Rosen R, Kipshidze N, Kipshidze N, Fried M. Transcatheter Bariatric Embolotherapy for Weight Reduction in Obesity. J Am Coll Cardiol. 2020 Nov 17;76(20):2305-2317. doi: 10.1016/j.jacc.2020.09.550.

  PMID: 33183504 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Endobar Solutions LLC

nodar@endobarsolutions.com

8456800424

Study Officials

• Martin Fried, MD

  OB klinika a.s., Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Peter Neuzil, MD

  Na Homolce Hospital, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Vivek Reddy, MD

  Mount Sinai Medical Center, New York, NY, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Interventional Group: These subjects will undergo catheter-based embolization. * Sham Control Group: These subjects will not undergo femoral artery catheterization. Instead, lidocaine will be injected subcutaneously at the femoral artery site in the Sham Control group. Since all patients will have received at least sedation, they will not be aware of what has been done, and thus be blind to their treatment assignment
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 9, 2017
• First Posted: June 14, 2017
• Study Start: February 8, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)