BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
NCT ID: NCT03189927
Last Updated: 2017-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
15 participants
INTERVENTIONAL
2017-07-01
2019-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Metal Stents on Benign Esophageal Lesions
NCT01238913
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
NCT01221311
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
NCT01699542
A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia
NCT03186014
Bougiecap for Treatment of Benign Stenosis in GI Tract
NCT03349021
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BD-Covered stent
Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae
BD-Covered esophageal stent
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BD-Covered esophageal stent
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
* Appropriate cultural level and understanding of the study
* Willingness to participate voluntarily in the study and give written informed consent
* Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
* Ability to undergo periodic endoscopic follow-up.
Exclusion Criteria
* Simultaneous participation in another clinical study
* Life expectancy of less than 12 months
* Malignant esophageal stricture
* Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
* Undergone an esophageal stent implantation before.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ELLA-CS , sro
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL.59222.091.16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.