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
|Condition or disease||Intervention/treatment||Phase|
|Arterial Embolization Other Surgical Procedures Obesity||Device: BeadBlock 300 - 500 Micron Procedure: Left Gastric Artery Embolization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Adverse Events [ Time Frame: 1 year ]Safety outcomes involving the use of left gastric artery embolization for the purpose of weight loss.
- Change in BMI [ Time Frame: baseline, 1 year ]
- Quality of life [ Time Frame: 1 year ]SF36-V2 / pre and post procedure to determine the changes of quality in life; everyday activities
- Appetite hormone levels [ Time Frame: 1 year ]Measuring changes in ghrelin, leptin, and CCK before and after left gastric embolization
- Change in overall weight of subjects [ Time Frame: baseline, 1 year ]
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
|United States, Ohio|
|Dayton Interventional Radiology|
|Dayton, Ohio, United States, 45409|
|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|