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

September 11, 2022 updated by: Endobar Solutions LLC

Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People With Obesity

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha 3 - Žižkov, Czechia, 130 00
        • OB klinika a.s., Pod Krejcárkem 975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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.
    • Malignancy in the last 5 years (except for non-melanoma skin cancer).
    • Evidence of other significant organ system dysfunction (e.g. cirrhosis, renal failure)
    • Pregnant or lactating.
    • History of substance abuse in last 3 years.
    • Thyroid Stimulating Hormone (TSH) >2.0 x upper limit of normal at screening.
    • Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 5 years.
    • Taking diuretic medication for congestive heart failure or edema.
    • Evidence of significant mucosal inflammation, ulceration or ischemia detected on endoscopy, and those with unsuitable left gastric anatomy as judged by the study site physician will be excluded
    • Psychiatric illness that could affect compliance with the study, as judged by the site principle investigator.
    • Unable to complete screening requirements (compliance with visits and dietary record)
    • Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
    • Chronic abdominal pain that would potentially complicate management.
    • Unstable weight (>3% change; self-reported) over the previous 2 months at time of screening.
    • Subjects whom the site investigator, research team, or the study medical monitor feel is not able to participate in the study for any reason, including poor general health or unable/unwilling to follow the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sedation and subcutaneous lidocaine
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
Bariatric embolization with microspheres using Endobar Infusion Catheter System
Behavioral: Behavioral therapy
Healthy diet and exercise
Experimental: interventional: bariatric embolization
• 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
Bariatric embolization with microspheres using Endobar Infusion Catheter System
Behavioral: Behavioral therapy
Healthy diet and exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
  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
Time Frame: 12 months post-randomization
The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.
12 months post-randomization
Absolute Weight Loss (kg)
Time Frame: 6 months post-procedure/sham and 12 months post-procedure

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Excess Body Weight (%EBWL) Loss
Time Frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure

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.
1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Weight Loss ≥5%
Time Frame: 6 months post-procedure/sham
Proportion of subjects who achieve ≥5% total body weight loss from baseline vs. those who do not
6 months post-procedure/sham
6 Month Change in Lipids
Time Frame: 6 months post-procedure/sham
6-month change (from baseline) in lipids for both groups. Unit of Measure: mg/dL
6 months post-procedure/sham
6 and 12 Month Change in Blood Pressure
Time Frame: 6 months post-procedure/sham and 12 months post-procedure

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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ghrelin Levels
Time Frame: [Time Frame: 6-12 months]
Unit of Measure: pg/mL
[Time Frame: 6-12 months]
Glucagon-like Peptide 1 Concentrations
Time Frame: [Time Frame: 6-12 months]
Changes in Glucagon-like peptide 1 concentrations Unit of Measure: pg/mL
[Time Frame: 6-12 months]
Oral Glucose Tolerance and Insulin Sensitivity
Time Frame: [Time Frame: 6-12 months]
Changes in OGTT and Insulin Sensitivity Unit of measure:milligrams/deciliter (mg/dL)
[Time Frame: 6-12 months]
Insulin Sensitivity
Time Frame: [Time Frame: 6-12 months]
Unit of measure: mg/min
[Time Frame: 6-12 months]
Changes in Mood (Depression/Anxiety)
Time Frame: [Time Frame: 6-12 months]
Unit of Measure: Beck Depression Index
[Time Frame: 6-12 months]
Change in Quality-of-life
Time Frame: [Time Frame: 6-12 months]
Change in the subdomains and overall Quality of Life Unit of Measure: IWQOL
[Time Frame: 6-12 months]
Change in Eating Behavior
Time Frame: [Time Frame: 6-12 months]
Unit of Measure: Eating Questionnaire Scores
[Time Frame: 6-12 months]
Change in Volume of Meal Test Consumed to Achieve Satiation: Satiation Drink Test.
Time Frame: [Time Frame: 6-12 months]
Change in satiety and other parameters associated with this test Unit of Measure: numerical scale from 0-5
[Time Frame: 6-12 months]
Results From Endoscopy
Time Frame: 12 months
Photos and clinical reports analyzed
12 months
Gastric Motility/Emptying
Time Frame: [Time Frame: 6-12 months]
Unit of Measure: (t 1/2) in minutes
[Time Frame: 6-12 months]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endobar Solutions LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Na Homolce Hospital
OB KLINIKA a.s. Pod Krejcárkem 975 Praha 3 - Žižkov Tel.: +420 255 725 110
High Tech Med Consult Frimlova 1322/4e 15500 Prague 5 Czech Republic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESC-14-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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