Gastric Arterial Embolization for Weight Loss

NCT02872740 | Unknown

• 1 other identifier: 15-9576
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events

  1 year

Secondary Outcomes (2)

• Weight

  1 year

• Cardiovascular risk factors

  1 year

Study Arms (2)

Embolization of Left Gastric Artery

EXPERIMENTAL

These patients will have their left gastric artery embolized

Procedure: Embolization of Left Gastric Artery

Embolization of Gastroepiploic Artery

EXPERIMENTAL

These patients will have their gastroepiploic artery embolized

Procedure: Embolization of Gastroepiploic Artery

Interventions

Embolization of Left Gastric Artery PROCEDURE

Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles

Embolization of Left Gastric Artery

Embolization of Gastroepiploic Artery PROCEDURE

Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles

Embolization of Gastroepiploic Artery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc, MD, FRCPC, FSIR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share