Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364553
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-03
Brief Title:
Esophageal Self-expandable Metal Stent for Malignant Strictures a Safety and Efficacy Study
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Esophageal Self-expandable Metal Stent for Malignant Strictures a Safety and Efficacy Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENTRANCE
Brief Summary:
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
Detailed Description:
Objective To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent SEMS for palliation of patients with malignant dysphagia
Study design Single center prospective observational non-randomized clinical study
Study population A total of 20 patients with malignant dysphagia will be included Sample size calculation does not apply for this type of study Outcome of the study efficacy and safety will be compared to our historic esophageal stent database including over 1000 patients
Study design Single center prospective observational non-randomized clinical study
Study population A total of 20 patients with malignant dysphagia will be included Sample size calculation does not apply for this type of study Outcome of the study efficacy and safety will be compared to our historic esophageal stent database including over 1000 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None