Morbid ObesityBEAT ObesityNCT02165124

Bariatric Embolization of Arteries for the Treatment of Obesity

A study testing Artificial Embolization Device in people with Morbid Obesity, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is evaluate the safety and effectiveness of bariatric embolization as a minimally-invasive image-guided procedure for morbid obesity. In this procedure, specific blood vessels to the stomach are blocked in order to suppress some of the body's signals for feeling hungry, leading to weight… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Morbid Obesity
What is being tested?: Artificial Embolization Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing, able and mentally competent to provide written informed consent.
Body mass index (BMI) between 40-60.
Residence within 25 miles of the enrolling institution
Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.
Suitable for protocol therapy as determined by the interventional radiology Investigator.
Adequate hematological, hepatic and renal function as follows:

Show all 10Show fewer

Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L International Normalized Ratio (INR) <1.5
Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L
Renal Estimated Glomerular Filtration Rate (GFR) > 60ml/min.1.73m2
Aged 18 years or older.

Who cannot join

Prior history of gastric pancreatic, hepatic, and/or splenic surgery
Prior radiation to the upper abdomen
Prior embolization to the stomach, spleen or liver
Portal venous hypertension
Prior or current history of peptic ulcer disease
Hiatal Hernia

Show all 22Show fewer

Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
Active H. Pylori infection
Weight greater than 400 pound
Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute
Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
Complicated arterial anatomic variants including left gastric artery arising from the aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery arising from the left gastric artery.
Pregnancy
Preexisting chronic abdominal pain
Positive stool occult study
Abnormal Endoscopy
Abnormal Nuclear Gastric Motility examination
American Society of Anaesthesiologists (ASA) Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.
History of Inflammatory Bowel Disease
Autoimmune disease
Cirrhosis
Known history of allergy to iodinated contrast media

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

Morbid obesity is currently treated with diet and exercise, medications, and surgery. This study is designed to help treat obesity using a minimally invasive, non-surgical, angiographic (through the blood vessel) approach. This procedure is similar to a common procedure used to treat bleeding within the stomach. This version of the procedure has been named "bariatric embolization".

Although there are over 40 hormones that limit food intake, there is only one hormone, ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has been a target for the treatment of obesity and weight loss. More recently, ghrelin has been shown to have a significant role in the long-term effect of weight loss in bariatric (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated patients.

Recent data collected in animals in has shown that blocking blood vessels to a particular portion of the stomach (bariatric embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5 people, there was a decrease in ghrelin levels and weight loss in the first month after the procedure, but there is no information about the effects of the procedure over longer periods of time.

The investigator hopes to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.

Conditions: Morbid Obesity
Being tested: Artificial Embolization Device
Keywords: Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss
Medical subject headings: Obesity, Morbid, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial Embolization DeviceDevice
Also called Device Product Codes: 85 NAJ, Classification Name: Artificial Embolization Device, Regulation Numbers: 21 CFR 882.5950
Embosphere Microspheres

Study groups in NCT02165124
Study group	Role	What they receive
Intervention/Bariatric Embolization	Experimental	Not described Receives: Device: Artificial Embolization Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Weight Change
This will be assessed by Percentage of excess weight loss (EWL). Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%).
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Mar 2018

First posted17 Jun 2014 (estimated)
Study startJun 2014
Primary completionDec 2017
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Morbid ObesityStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02165124
Sponsor's protocol ID: NA_00093563
Acronym: BEAT Obesity
Status last verified: Nov 2018
First submitted: 11 Jun 2014
Last updated: 5 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom

All Morbid Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bariatric Embolization of Arteries for the Treatment of Obesity
ClinicalTrials.gov ID: NCT02165124
Acronym / sponsor ID: BEAT Obesity / NA_00093563
Conditions: Morbid Obesity
Keywords: Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Icahn School of Medicine at Mount Sinai
Study start: Jun 2014
Primary completion: Dec 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 17 Jun 2014 (estimated)
Results: Posted 5 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigator hopes to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention/Bariatric Embolization	Experimental	Device: Artificial Embolization Device

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Willing, able and mentally competent to provide written informed consent.
Body mass index (BMI) between 40-60.
Residence within 25 miles of the enrolling institution
Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.
Suitable for protocol therapy as determined by the interventional radiology Investigator.

Key exclusion criteria (22 listed)

Prior history of gastric pancreatic, hepatic, and/or splenic surgery
Prior radiation to the upper abdomen
Prior embolization to the stomach, spleen or liver
Portal venous hypertension
Prior or current history of peptic ulcer disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Artificial Embolization DeviceAlso: Device Product Codes: 85 NAJ, Classification Name: Artificial Embolization Device, Regulation Numbers: 21 CFR 882.5950Embosphere Microspheres	Device	Intervention/Bariatric Embolization

Primary outcome

Percent Weight Change
Time frame: 12 Months
This will be assessed by Percentage of excess weight loss (EWL). Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%).

Results and safety

Results posted to the registry on 5 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention/Bariatric Embolization	20	15

Primary outcome: Percent Weight Change

Time frame: 12 Months. Mean (Standard Deviation). Unit: percentage of excess weight loss

Measure	Intervention/Bariatric Embolization n = 20
Value	11.5 (10.2)

Adverse events

Time frame: 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention/Bariatric Embolization	0 of 20 (0%)	8 of 20 (40%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Morbid Obesity

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clifford R Weiss, M.D. principal investigator

Johns Hopkins University

Aravind Arepally, M.D. principal investigator

Piedmont Healthcare

Dara L Kraitchman, V.M.D., Ph.D. principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Embolization Device in people with Morbid Obesity, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Change (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02165124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.