Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically
Arterial Embolization · Other Surgical Procedures · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02248688 ↗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
| Outcome | Result | p-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
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
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.