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Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GETLEAN)

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ClinicalTrials.gov Identifier: NCT02248688
Recruitment Status : Unknown
Verified February 2017 by Dayton Interventional Radiology.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Dayton Interventional Radiology

Brief Summary:
The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is not designed to achieve new indications for this device.

Condition or disease Intervention/treatment Phase
Arterial Embolization Other Surgical Procedures Obesity Device: BeadBlock 300 - 500 Micron Procedure: Left Gastric Artery Embolization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GET LEAN)
Study Start Date : September 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Embolic Agent - BeadBlock
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
Device: BeadBlock 300 - 500 Micron
Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Other Name: GET LEAN

Procedure: Left Gastric Artery Embolization



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]
    Safety outcomes involving the use of left gastric artery embolization for the purpose of weight loss.


Secondary Outcome Measures :
  1. Change in BMI [ Time Frame: baseline, 1 year ]
  2. Quality of life [ Time Frame: 1 year ]
    SF36-V2 / pre and post procedure to determine the changes of quality in life; everyday activities

  3. Appetite hormone levels [ Time Frame: 1 year ]
    Measuring changes in ghrelin, leptin, and CCK before and after left gastric embolization

  4. Change in overall weight of subjects [ Time Frame: baseline, 1 year ]


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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic table <400lbs due to table weight limits Appropriate anesthesia risk as determined by certified anesthesia provider evaluation preprocedure.

Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and also participate in the informed consent).

Subjects who have failed previous attempts at weight loss through diet, exercise, and behavior modification (as it is recommended that conservative options, such as supervised low calorie diets combined with behavior therapy and exercise, should be attempted prior to enrolling in this study).

Exclusion Criteria:

Less than 22 years of age 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 Serum creatinine > 1.8 mg/dL History of kidney problems 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 (acrylamido polyvinyl alcohol macromer) 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 or antiplatelet drugs Patients currently taking or requiring chronic use of 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.

Patients with any contraindications for monitored anesthesia care or general surgery Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism 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.

Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.

Patients with hiatal hernia Patients with known aortic disease, such as dissection or aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy


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): NCT02248688


Locations
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United States, Ohio
Dayton Interventional Radiology
Dayton, Ohio, United States, 45409
Sponsors and Collaborators
Dayton Interventional Radiology
Ohio State University
Investigators
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Principal Investigator: Mubin I Syed, MD Dayton Interventional Radiology
Study Director: Azim Shaikh, MD, MBA Dayton Interventional Radiology
Study Director: Sumeet Patel Dayton Interventional Radiology

Publications:

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Responsible Party: Dayton Interventional Radiology
ClinicalTrials.gov Identifier: NCT02248688     History of Changes
Other Study ID Numbers: Q131650
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Dayton Interventional Radiology:
Bariatric Embolization
Gastric Artery Emboliziation
Left Gastric Artery Embolization
Morbid Obesity
Obesity
Weight Loss
Ghrelin
Embolization

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms