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Gastric Arterial Embolization for Weight Loss

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Embolization of Left Gastric Artery
Embolization of Gastroepiploic Artery
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease

Exclusion Criteria:

Basic

Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment

Gastrointestinal

Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L

Cardiovascular

Known aortic pathology such as aneurysm or dissection Peripheral arterial disease

Renal

Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2

Hematologic/Immunologic/Oncologic/Infectious

Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7

Psychiatric

Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Embolization of Left Gastric Artery

    Embolization of Gastroepiploic Artery

    Arm Description

    These patients will have their left gastric artery embolized

    These patients will have their gastroepiploic artery embolized

    Outcomes

    Primary Outcome Measures

    Adverse events
    Adverse events

    Secondary Outcome Measures

    Weight
    weight change
    Cardiovascular risk factors
    serum lipids, hemoglobin A1C, blood pressure, sleep apnea

    Full Information

    First Posted
    August 16, 2016
    Last Updated
    August 18, 2016
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02872740
    Brief Title
    Gastric Arterial Embolization for Weight Loss
    Official Title
    Gastric Arterial Embolization for Weight Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Title: Embolization of Gastric Arterial Supply for Weight Loss Sample size: 10 patients Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery. Study Design: Single center, randomized, prospective, non-blinded pilot study. Study Duration: 12 months (November 2015 - December 2015). Agent: 150-250 micron polyvinyl alcohol particles Primary objective: To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients. Primary objective measure: The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Embolization of Left Gastric Artery
    Arm Type
    Experimental
    Arm Description
    These patients will have their left gastric artery embolized
    Arm Title
    Embolization of Gastroepiploic Artery
    Arm Type
    Experimental
    Arm Description
    These patients will have their gastroepiploic artery embolized
    Intervention Type
    Procedure
    Intervention Name(s)
    Embolization of Left Gastric Artery
    Intervention Description
    Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
    Intervention Type
    Procedure
    Intervention Name(s)
    Embolization of Gastroepiploic Artery
    Intervention Description
    Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    Adverse events
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Weight
    Description
    weight change
    Time Frame
    1 year
    Title
    Cardiovascular risk factors
    Description
    serum lipids, hemoglobin A1C, blood pressure, sleep apnea
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease Exclusion Criteria: Basic Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment Gastrointestinal Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L Cardiovascular Known aortic pathology such as aneurysm or dissection Peripheral arterial disease Renal Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2 Hematologic/Immunologic/Oncologic/Infectious Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7 Psychiatric Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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