Gastric Arterial Embolization for Weight Loss
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Embolization of Left Gastric Artery
These patients will have their left gastric artery embolized
|
Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
|
|
Experimenteel: Embolization of Gastroepiploic Artery
These patients will have their gastroepiploic artery embolized
|
Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adverse events
Tijdsspanne: 1 year
|
Adverse events
|
1 year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Weight
Tijdsspanne: 1 year
|
weight change
|
1 year
|
|
Cardiovascular risk factors
Tijdsspanne: 1 year
|
serum lipids, hemoglobin A1C, blood pressure, sleep apnea
|
1 year
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15-9576
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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