Actively Recruiting

Phase Not Applicable
Age: 18Years - 91Years
All Genders
NCT05431738

Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

Led by Société Française d'Endoscopie Digestive · Updated on 2024-07-30

180

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

CONDITIONS

Official Title

Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

Who Can Participate

Age: 18Years - 91Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient of both sexes aged 18 or over
  • Admitted for dysphagia due to locally advanced or metastatic tumoral stenosis of the gastroesophageal junction
  • Classified as ASA 1, ASA 2, or ASA 3
  • Not participating in another clinical study
  • Signed informed consent provided
  • Covered by the social security system
Not Eligible

You will not qualify if you...

  • Stenosis caused by external compression from an extra digestive mass
  • Contraindications to procedures needed for stent insertion
  • History of mediastinal radiotherapy or esophageal surgery
  • Age under 18 or over 90 years
  • Classified as ASA 4 or ASA 5
  • Pregnant women
  • Unable to give personal consent
  • No signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

French Society of Digestive Endoscopy

Paris, France, 75006

Actively Recruiting

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Research Team

D

David KARSENTI, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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