Bariatric Embolization Trial for the Obese Nonsurgical

NCT03601273 | Unknown Phase 1

• 1 other identifier: REB17-0610
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety profile of bariatric embolizations and confirm published reports of sustained post-procedural weight loss, and pathologically assess post-procedural metabolic effects.

Conditions

Obesity; Weight Loss; Body Weight; Morbid Obesity

Keywords

left gastric artery embolization; bariatric embolization; interventional radiology; obesity; morbid obesity; weight loss

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Safety outcomes involving the use of left gastric artery embolization

  5 years

Secondary Outcomes (3)

• Change in Body mas index (BMI)

  5 years

• Percentage estimated body weight loss (EBWL)

  5 years

• Change in concentration of Ghrelin-producing cells

  30 days post-operative

Interventions

Left gastric artery embolization PROCEDURE

450-micron Embozene microparticles will be used intraarterially to occlude the left gastric artery and its branches. 30-day post-embolization endoscopic biopsy

Also known as: bariatric embolization

Eligibility Criteria

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

You may qualify if:

• Patients who are bariatric surgical candidates; however, have refused surgery.
• BMI \>40
• BMI between 35 and 40 with medical comorbidities
• Patients who meet criteria for medical management of obesity with BMI ≥ 35
• Age ≥ 18 years
• Willing, able and mentally competent to provide written informed consent

You may not qualify if:

• Age less than 18 years of age
• Inability to lay supine on an angiographic table \<500lbs due to table weight limits
• Inappropriate anesthesia risk as determined by certified anesthesia provider.
• Presence of a contraindication to endovascular therapy
• 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
• Severe renal impairment resulting in unacceptable risk of contrast-induced nephropathy
• 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
• Enrolled in another study
• Any patient who has a history of allergic reaction to iodinated contrast

Sponsors & Collaborators

• University of Calgary: lead
• Calgary Adult Bariatric Surgery Clinic: collaborator
• Peter Lougheed Center, Mayfair Diagnostics: collaborator

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Darshan Bakshi, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Oliver Halliwell, MD

  University of Calgary

  STUDY DIRECTOR

• Emeka Nzekwu, MD

  University of Calgary

  STUDY DIRECTOR

Central Study Contacts

Emeka Nzekwu, MD

CONTACT

5874349886; nzekwu@ualberta.ca

Darshan Bakshi, MD

CONTACT

darshanbakshi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 26, 2018

Record last verified: 2018-07