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N/A N=5 Treatment

Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically

Arterial Embolization · Other Surgical Procedures · Obesity

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Body Weight Average 6 Months Post-Procedure — 237.6 lbs.

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
BeadBlock 300 - 500 Micron (Device); Left Gastric Artery Embolization (Procedure)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Dayton Interventional Radiology
Primary completion
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Weight Average 6 Months Post-Procedure
237.6
PRIMARY
Body Weight Average 12 Months Post-Procedure
238
PRIMARY
Change in Average Body Weight From Baseline at 6 Months Post-Procedure
16.6
PRIMARY
Change in Average Body Weight From Baseline at 12 Months Post-Procedure
-16.2
PRIMARY
Percentage of Excess Body Weight Loss at 6 Months Post-Procedure
14.8
PRIMARY
Percentage of Excess Body Weight Loss at 12 Months Post-Procedure
15.1
PRIMARY
Average Ghrelin Hormone Levels at 6 Months Post-Procedure
605.4
PRIMARY
Average Ghrelin Hormone Levels at 12 Months Post-Procedure
21.1
PRIMARY
Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure
-9.9
PRIMARY
Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure
-19.2
SECONDARY
Average Leptin Hormone Levels at 6 Months Post-Procedure
19.4
SECONDARY
Average Leptin Hormone Levels at 12 Months Post-Procedure
21.1
SECONDARY
Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure
-31.2
SECONDARY
Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure
21.1
SECONDARY
Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure
32.4
SECONDARY
Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure
44.6
SECONDARY
Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure
-15.1
SECONDARY
Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure
56.4
SECONDARY
Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure
59.5
SECONDARY
Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure
9.7
SECONDARY
QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure
65.79
SECONDARY
Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure
16.0
SECONDARY
QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure
57
SECONDARY
Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure
8.9
SECONDARY
QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure
63.1
SECONDARY
Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure
14.9
SECONDARY
6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels
6.3
SECONDARY
12-Month Post-Procedure HgA1c Levels
5.9

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.

Eligibility Criteria

Inclusion Criteria

Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic table 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02248688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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