Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

June 5, 2016 updated by: Gao-jun Teng, Zhongda Hospital

The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss.

Although there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
50

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.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Body mass index (BMI) >30.
  2. No history of gastrointestinal surgery.
  3. Willing, able and mentally competent to provide written informed consent.
  4. Suitable for protocol therapy as determined by the interventional radiology Investigator.

  5. Adequate hematological, hepatic and renal function as follows:

    Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2

  6. Aged between18 and 65 years old.
  7. More than one year's follow-up can be obtained reliably

Exclusion Criteria:

  1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
  2. Prior embolization to the stomach, spleen or liver
  3. Prior or current history of peptic ulcer disease
  4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
  5. Portal venous hypertension or cirrhosis
  6. Less than 18 years or older than 65 years of age
  7. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute an estimated glomerular filtration rate of < 60 milliliters per minute
  8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
  9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
  10. Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
  11. Patients currently taking or requiring chronic use of NSAID or steroid medications

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: left gastric artery embolization
Patients undergoing left gastric artery embolization
Procedure: left gastric artery embolization
Active Comparator: healthy diet and exercise
Patients undergoing healthy diet and exercise
Behavioral: 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: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months

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
Blood pressure
Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Lipid Profile
Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Number of Patients with Adverse Events
Time Frame: post-op 30 days
Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
post-op 30 days
Ghrelin levels
Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content
Time Frame: Baseline, post-op 1 month,6 months,12 months
Abdominal fat content detected by MRI.
Baseline, post-op 1 month,6 months,12 months
Leptin levels
Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Results of Gastroendoscopic Examination
Time Frame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Photos and clinical reports will be analyzed.
Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Quality of Life Parameters Survey
Time Frame: 12 months
N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
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.
Zhongda Hospital

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: Gao-jun Teng, Ph.D,MD, Zhongda Hospital Southeast University

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

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.
May 1, 2016

Primary Completion (Anticipated)

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.
October 1, 2017

Study Completion (Anticipated)

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.
May 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 25, 2016

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.
May 25, 2016

First Posted (Estimate)

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.
May 30, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
June 7, 2016

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.
June 5, 2016

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.
June 1, 2016

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.
  • 2015ZDSYLL068.0

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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