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Tests treatment safety and results for Oesophageal Cancer
Official title Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
ClinicalTrials.gov ID: NCT06364553
What this study is testing
- What it's testing
- A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic...
- Requiring treatment for dysphagia (Ogilvie score of 2-41);
- Life expectancy of less than 12 months;
- Written informed consent;
- Age ≥ 18 years.
You likely can't join if
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Coagulopathy (not corrected prior to stent placement);
- Patients with eosinophilic esophagitis or an esophageal motility disorder;
See the full eligibility criteria
- Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- Requiring treatment for dysphagia (Ogilvie score of 2-41);
- Life expectancy of less than 12 months;
- Written informed consent;
- Age ≥ 18 years.
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Coagulopathy (not corrected prior to stent placement);
- Patients with eosinophilic esophagitis or an esophageal motility disorder;
- Nickel titanium (Nitinol) allergy.
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.