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Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
RECRUITINGN/ASponsored by Société Française d'Endoscopie Digestive
Actively Recruiting
PhaseN/A
SponsorSociété Française d'Endoscopie Digestive
Started2022-09-01
Est. completion2025-09-01
Eligibility
Age18 Years – 91 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05431738
Summary
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.
Eligibility
Age: 18 Years – 91 YearsHealthy volunteers accepted
Inclusion Criteria: 1. Patient of both sexes aged 18 or over. 2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic. 3. Patient ASA 1, ASA 2, ASA 3 4. Absence of participation in another clinical study 5. Signed Informed Consent 6. Patients benefiting from the social security system. Exclusion Criteria: 1. Patient referred for stenosis by extrinsic compression by an extra digestive mass 2. Patients with contraindications relating to the procedures essential for the introduction of a stent 3. Mediastinal radiotherapy or esophageal surgery history 4. Patient under 18 or over 90 5. Patient ASA 4, ASA 5 6. Pregnant Woman 7. Patient unable to give personal consent 8. Absence of signed informed consent
Conditions3
CancerGastroEsophageal CancerStent Migration
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Actively Recruiting
PhaseN/A
SponsorSociété Française d'Endoscopie Digestive
Started2022-09-01
Est. completion2025-09-01
Eligibility
Age18 Years – 91 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05431738