NCT05431738 Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)
| NCT ID | NCT05431738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Société Française d'Endoscopie Digestive |
| Condition | Stent Migration |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2022-09-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05431738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 91 Years, studying Stent Migration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05431738 currently recruiting?
Yes, NCT05431738 is actively recruiting participants. Contact the research team at karsenti@club-internet.fr for enrollment information.
Where is the NCT05431738 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05431738 clinical trial?
NCT05431738 is sponsored by Société Française d'Endoscopie Digestive. The trial plans to enroll 180 participants.