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Bariatric Embolization Trial for the Obese Nonsurgical (BET-ON)

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ClinicalTrials.gov Identifier: NCT03601273
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborators:
Calgary Adult Bariatric Surgery Clinic
Peter Lougheed Center, Mayfair Diagnostics
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
The purpose of this study is to assess the safety profile of bariatric embolizations and confirm published reports of sustained post-procedural weight loss, and pathologically assess post-procedural metabolic effects.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Body Weight Morbid Obesity Procedure: Left gastric artery embolization Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariatric Embolization Trial for the Obese Nonsurgical
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Intervention Details:
  • Procedure: Left gastric artery embolization

    450-micron Embozene microparticles will be used intraarterially to occlude the left gastric artery and its branches.

    30-day post-embolization endoscopic biopsy

    Other Name: bariatric embolization


Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 5 years ]
    Safety outcomes involving the use of left gastric artery embolization


Secondary Outcome Measures :
  1. Change in Body mas index (BMI) [ Time Frame: 5 years ]
    kg/m2

  2. Percentage estimated body weight loss (EBWL) [ Time Frame: 5 years ]
  3. Change in concentration of Ghrelin-producing cells [ Time Frame: 30 days post-operative ]
    Concentration of Ghrelin-producing cells pre-embolization obtained through endoscopic biopsy and measured by cells per milliliter, will be subtracted from the concentration of Ghrelin-producing cells obtained post-embolization from endoscopic biopsy. This value will be converted into a percentage change and reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who are bariatric surgical candidates; however, have refused surgery.
  • BMI >40
  • BMI between 35 and 40 with medical comorbidities
  • Patients who meet criteria for medical management of obesity with BMI ≥ 35
  • Age ≥ 18 years
  • Willing, able and mentally competent to provide written informed consent

Exclusion Criteria:

  • Age less than 18 years of age
  • Inability to lay supine on an angiographic table <500lbs due to table weight limits
  • Inappropriate anesthesia risk as determined by certified anesthesia provider.
  • Presence of a contraindication to endovascular therapy
  • Major surgery within the past eight weeks
  • Previous gastric, pancreatic, hepatic and splenic surgery
  • Previous radiation therapy to the left or right upper quadrant
  • Previous gastric, hepatic, or splenic embolization
  • Any history of portal venous hypertension
  • Severe renal impairment resulting in unacceptable risk of contrast-induced nephropathy
  • Pregnant or intend to become pregnant within one year
  • History of severe bleeding disorder (platelet count less than 40,000)
  • Allergy to materials in the embolic agents
  • Enrolled in another study
  • Any patient who has a history of allergic reaction to iodinated contrast
  • Abnormal baseline gastric emptying study
  • Patients taking anti-coagulants (anti-platelets fine)
  • Patients currently taking or requiring chronic use of non steroidal anti-inflammatory drugs (NSAID) or steroid medications
  • Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting
  • Patients with any history of peptic ulcer disease
  • Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities.
  • Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.
  • Patients with known aortic disease, such as dissection or aneurysm
  • Patients with comorbidities such as cancer
  • Patients with any abnormality on their baseline esophagogastroduodenoscopy (EGD)
  • Patients with a CT Angiogram demonstrating an anatomical variant in left gastric artery anatomy
  • Patients with any contraindications for monitored anesthesia care or general surgery
  • Patients with secondary causes of obesity such as Cushing's disease, hypothyroidism, or abnormal testosterone readings
  • Patients with active substance abuse or alcoholism
  • Patients with defined noncompliance with previous medical care
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601273


Contacts
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Contact: Emeka Nzekwu, MD 5874349886 nzekwu@ualberta.ca
Contact: Darshan Bakshi, MD darshanbakshi@gmail.com

Sponsors and Collaborators
University of Calgary
Calgary Adult Bariatric Surgery Clinic
Peter Lougheed Center, Mayfair Diagnostics
Investigators
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Principal Investigator: Darshan Bakshi, MD University of Calgary
Study Director: Oliver Halliwell, MD University of Calgary
Study Director: Emeka Nzekwu, MD University of Calgary
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03601273    
Other Study ID Numbers: REB17-0610
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
left gastric artery embolization
bariatric embolization
interventional radiology
obesity
morbid obesity
weight loss
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight Changes