An interventional study of BD-Covered esophageal stent in Benign Esophageal Stricture, sponsored by Radboud University Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
50 studies on the registry are indexed under Esophageal Stenosis; 11 are open to participants now.
This study's planned enrollment of 15 is below the median of 24 across 41 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae
Device: BD-Covered esophageal stent
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Incidence of treatment associated adverse events during follow-up (safety)
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
Time frame: 6 months
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Time frame: 1 day
Esophageal pain, measured with VAS during follow-up after stent placement
Pain will be measured with the VAS during follow-up
Time frame: 6 months
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Recurrent dysphagia during follow-up
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center