Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Embolization of Left Gastric Artery
These patients will have their left gastric artery embolized
Embolization of Left Gastric Artery
Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
Embolization of Gastroepiploic Artery
These patients will have their gastroepiploic artery embolized
Embolization of Gastroepiploic Artery
Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
Interventions
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Embolization of Left Gastric Artery
Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
Embolization of Gastroepiploic Artery
Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Martin Simons
BSc, MD, FRCPC, FSIR
Other Identifiers
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15-9576
Identifier Type: -
Identifier Source: org_study_id
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