Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically

NCT02248688 | Completed Results DMC

• 1 other identifier: Q131650
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Embolization; Other Surgical Procedures; Obesity

Keywords

Bariatric Embolization; Gastric Artery Emboliziation; Left Gastric Artery Embolization; Morbid Obesity; Obesity; Weight Loss; Ghrelin; Embolization

Outcome Measures

Primary Outcomes (10)

• Body Weight Average 6 Months Post-Procedure

  The mean body weight of all 5 participants at 6-Months post-procedure.

  6-Month

• Body Weight Average 12 Months Post-Procedure

  The mean body weight of all 5 participants at 12-Months post-procedure.

  12-Month

• Change in Average Body Weight From Baseline at 6 Months Post-Procedure

  Average change in body weight lost. Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

  Baseline, 6 Months

• Change in Average Body Weight From Baseline at 12 Months Post-Procedure

  Average change in body weight lost. Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

  Baseline, 12 Months

• Percentage of Excess Body Weight Loss at 6 Months Post-Procedure

  Calculated as the average of participants: (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

  Baseline, 6 Month

• Percentage of Excess Body Weight Loss at 12 Months Post-Procedure

  Calculated as the average of participants: (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

  Baseline, 12 Month

• Average Ghrelin Hormone Levels at 6 Months Post-Procedure

  The mean of participant's 6-Month post-procedure Ghrelin levels.

  6-Month

• Average Ghrelin Hormone Levels at 12 Months Post-Procedure

  The mean of participant's 12-Month post-procedure Ghrelin levels.

  12-Month

• Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure

  Calculated as the average of participants: (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100

  6-Month, Baseline

• Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure

  Calculated as the average of participants: (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100

  12-Month, Baseline

Secondary Outcomes (18)

• Average Leptin Hormone Levels at 6 Months Post-Procedure

  6-Month

• Average Leptin Hormone Levels at 12 Months Post-Procedure

  12-Month

• Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure

  6-Month, Baseline

• Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure

  12-Month, Baseline

• Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure

  6-Month

Study Arms (1)

Embolic Agent - BeadBlock

OTHER

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; Procedure: Left Gastric Artery Embolization

Interventions

BeadBlock 300 - 500 Micron DEVICE

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.

Also known as: GET LEAN

Embolic Agent - BeadBlock

Left Gastric Artery Embolization PROCEDURE

Embolic Agent - BeadBlock

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Dayton Interventional Radiology: lead
• Ohio State University: collaborator

Study Sites (1)

Dayton Interventional Radiology

Dayton, Ohio, 45409, United States

Location

Related Publications (14)

• Rosch J, Dotter CT, Brown MJ. Selective arterial embolization. A new method for control of acute gastrointestinal bleeding. Radiology. 1972 Feb;102(2):303-6. doi: 10.1148/102.2.303. No abstract available.

  PMID: 4536688 BACKGROUND

• Bookstein JJ, Chlosta EM, Foley D, Walter JF. Transcatheter hemostasis of gastrointestinal bleeding using modified autogenous clot. Radiology. 1974 Nov;113(2):277-85. doi: 10.1148/113.2.277. No abstract available.

  PMID: 4547597 BACKGROUND

• Morris DC, Nichols DM, Connell DG, Burhenne HJ. Embolization of the left gastric artery in the absence of angiographic extravasation. Cardiovasc Intervent Radiol. 1986;9(4):195-8. doi: 10.1007/BF02577940.

  PMID: 3094950 BACKGROUND

• Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.

  PMID: 18796671 BACKGROUND

• Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.

  PMID: 24462005 BACKGROUND

• Paxton BE, Kim CY, Alley CL, Crow JH, Balmadrid B, Keith CG, Kankotia RJ, Stinnett S, Arepally A. Bariatric embolization for suppression of the hunger hormone ghrelin in a porcine model. Radiology. 2013 Feb;266(2):471-9. doi: 10.1148/radiol.12120242. Epub 2012 Nov 30.

  PMID: 23204538 BACKGROUND

• Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.

  PMID: 22367009 BACKGROUND

• Brown KT, Friedman WN, Marks RA, Saddekni S. Gastric and hepatic infarction following embolization of the left gastric artery: case report. Radiology. 1989 Sep;172(3):731-2. doi: 10.1148/radiology.172.3.2788892.

  PMID: 2788892 BACKGROUND

• Castaneda-Zuniga WR, Jauregui H, Rysavy J, Amplatz K. Selective transcatheter embolization of the upper gastrointestinal tract: an experimental study. Radiology. 1978 Apr;127(1):81-3. doi: 10.1148/127.1.81.

  PMID: 305577 BACKGROUND

• Bradley EL 3rd, Goldman ML. Gastric infarction after therapeutic embolization. Surgery. 1976 Apr;79(4):421-4.

  PMID: 1083078 BACKGROUND

• Prochaska JM, Flye MW, Johnsrude IS. Left gastric artery embolization for control of gastric bleeding: a complication. Radiology. 1973 Jun;107(3):521-2. doi: 10.1148/107.3.521. No abstract available.

  PMID: 4702528 BACKGROUND

• Robbins SM, Tuten TU, Clements JL, Fekete P. Angiographic diagnosis of gastric volvulus with report of a complication following left gastric artery embolization. Gastrointest Radiol. 1988;13(2):112-4. doi: 10.1007/BF01889038.

  PMID: 3258835 BACKGROUND

• Miller DL, Balter S, Cole PE, Lu HT, Schueler BA, Geisinger M, Berenstein A, Albert R, Georgia JD, Noonan PT, Cardella JF, St George J, Russell EJ, Malisch TW, Vogelzang RL, Miller GL 3rd, Anderson J; RAD-IR study. Radiation doses in interventional radiology procedures: the RAD-IR study: part I: overall measures of dose. J Vasc Interv Radiol. 2003 Jun;14(6):711-27. doi: 10.1097/01.rvi.0000079980.80153.4b.

  PMID: 12817038 BACKGROUND

• Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.

  PMID: 27567998 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations included: 1. Relatively Small Sample Size 2. Surgical Placebo Effect 3. Lack of Maintaining Diet and Caloric Intake Records 4. Diet Modification and Nutritional Supervision that could account for weight loss

Results Point of Contact

• Title: Mubin Syed, MD
• Organization: Dayton Interventional Radiology-Research

mubinsyed@aol.com

937-215-0878

Study Officials

• Mubin I Syed, MD

  Dayton Interventional Radiology

  PRINCIPAL INVESTIGATOR

• Azim Shaikh, MD, MBA

  Dayton Interventional Radiology

  STUDY DIRECTOR

• Sumeet Patel

  Dayton Interventional Radiology

  STUDY DIRECTOR

• Feras J Deek, BS, BA

  Dayton Interventional Radiology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).

Locations

US (1)