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Esophageal Multisegmented FCSEMS for Malignant Strictures

NCT04415463 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-01-12

No results posted yet for this study

Summary

Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.

Study design: Prospective observational nonrandomized clinical study.

Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.

Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.

Primary end points:

* Safety: complications and adverse events during follow-up with special attention to stent migration rates;
* Efficacy: technical success of stent placement.

Secondary end points:

* Recurrent dysphagia including its cause;
* Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
* Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
* Pain related to esophageal stent.

Conditions

  • Oesophageal Cancer
  • Esophageal Stent Stenosis

Interventions

DEVICE

Multisegmented fully covered self-expandable metal stent

Esophageal FC-SEMS

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415463 on ClinicalTrials.gov