Embolization of Arterial Gastric Supply in Obesity

NCT04207424 | Withdrawn DMC

• 1 other identifier: 19-005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.

Conditions

Morbid Obesity

Keywords

Bariatric embolization; Obesity; Metabolic syndrome

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events

  7 days post embolization

• Number of participants with adverse events

  1 month post embolization

• Number of participants with adverse events

  3 months post embolization

• Number of participants with adverse events

  6 months post embolization

• Number of participants with adverse events

  12 months post embolization

Secondary Outcomes (6)

• Change in weight

  Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization

• Change in abdominal circumference

  Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization

• Change in thigh circumferences

  Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization

• Change in Ghrelinemia

  Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization

• Change in Quality of life

  Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization

Study Arms (1)

Embolization

EXPERIMENTAL

Patients undergoing embolization of the gastro-epiploic arcade

Procedure: Emblization of the gastro-epiploic arcade

Interventions

Emblization of the gastro-epiploic arcade PROCEDURE

Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles

Embolization

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient aged ≥18 and ≤ 71 years old
• BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea
• Relative contraindication to bariatric surgery
• Able to sign informed consent.

You may not qualify if:

• General
• Impossible or unwilling to attend follow-up visits.
• Weight \> 250kg (weight limit of angiography table)
• Confirmed allergy to intravenous contrast agents.
• Pregnancy, breast feeding or willingness to conceive during the following year
• Impossible to maintain dorsal decubitus during intervention
• Life expectancy \< 1 year
• Current enrollment in another clinical trial
• Arterial anatomy rendering embolization very difficult or impossible (as evaluated by investigators)
• Patient under the protection of justice
• Patient under guardianship or trusteeship
• Gastro-intestinal
• Pre-existing chronic abdominal pain
• History of inflammatory bowel disease
• History of gastroparesis

Sponsors & Collaborators

• IHU Strasbourg: lead

Related Publications (24)

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MeSH Terms

Conditions

Obesity, Morbid; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Raoul POP, MD, PhD

  Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg

  PRINCIPAL INVESTIGATOR

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: December 16, 2019
• First Posted: December 20, 2019
• Study Start: March 23, 2020
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share