NCT01337206|Completed
SX ELLA Esophageal Degradable BD Stent System
DESTINY
Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
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DESTINY
Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
Sponsor study identifier
interventional
66
5 countries
8
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
January 2015
Actual (reported)The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2011
Actual (reported)April 18, 2011
Actual (reported)January 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)January 2015
Actual (reported)The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
3 - 6 months
Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion
6 - 12 months
Time to recurrent significant dysphagia
6 - 12 months
Time to dilation of recurrent stricture
6 - 12 months
6 months and 12 months incidence of repeat dilation
6 - 12 months
Serious and minor adverse events with possible or likely relation to the study Intervention
6 - 12 months
Stenting Arm
Dilation Arm
Treating benign esophageal lesions with the placement of a degradable stent
Treating benign esophageal lesions with standard dilation therapy
Clinique Universitaire Saint Luc
Brussels, 1000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
IRCCS Istituto Clinico Humanitas
Milan, 20089, Italy
Academic Medical Center
Amsterdam, 22700, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
University Medical Center Utrech
Utrecht, 3508, Netherlands
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.
Peter D. Siersema, MD, PhD
University Medical Center Utrech
66 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2011
First Posted
April 18, 2011
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University College of London Hospital
London, NW1 2PG, United Kingdom
Primary Completion
July 2014
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
February 6, 2015
Record last verified: 2015-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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