Embolization of Arterial Gastric Supply in Obesity

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Obesity is now an epidemic in the developed and developing world. Medical management is ineffective at population level. Metabolic surgery has been shown to be effective in achieving weight loss and controlling associated conditions. However, surgery is invasive and has associated complications. Furthermore, not every patient is interested in or eligible for surgery. Bariatric gastric embolization recently emerged as a promising minimally invasive alternative to open bariatric surgery. Data from several initial pilot clinical trials suggests that gastric embolization is safe and can induce weight loss. Previous studies have concentrated on left gastric artery embolization as the primary target vessel because it supplies the largest portion of the fundus. However, it may be desirable to target a different artery, specifically the left gastroepiploic which also supplies the fundus. The left gastric artery is spared in bariatric surgery because it supplies the residual pouch after the surgery. Embolization of the left gastric artery may result in worse healing in the event of follow-up surgery potentially excluding people should they subsequently want it or become eligible. 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. The target population consists of adult, morbidly obese patients with contraindication for bariatric surgery. Patients included in the study will be followed up for 12 months post bariatric embolization. The primary end point is procedural safety, defined as number and severity of adverse events occurring during the study period. Secondary end points include weight loss, evolution of weight and thigh circumferences, evolution of serum ghrelin levels and evolution of quality of life indexes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04207424
Study type	Interventional
Source	IHU Strasbourg
Contact
Status	Withdrawn
Phase	N/A
Start date	April 2021
Completion date	May 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Embolization of Arterial Gastric Supply in Obesity — Embargo

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms