SX ELLA Esophageal Degradable BD Stent System

Benign Esophageal Lesions Clinical Trial

— DESTINY  

Official title:

Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337206
• Other study ID #: 09-024
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: February 5, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)

Exclusion Criteria:

• Patient < 18 years old

• Patient is unwilling or unable to sign and date the informed consent

• Patient is unwilling or unable to comply with the follow-up schedule

• Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months

• Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study

• Patient with a life expectancy < 12 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Esophageal Lesions

Intervention

Device:
• Stenting with ELLA Biodegradable stent
Treating benign esophageal lesions with the placement of a degradable stent

Procedure:
• Standard Dilations
Treating benign esophageal lesions with standard dilation therapy

Locations

Country	Name	City	State
Belgium	Clinique Universitaire Saint Luc	Brussels
Belgium	University Hospitals Leuven	Leuven
Italy	IRCCS Istituto Clinico Humanitas	Milan
Netherlands	Academic Medical Center	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	University Medical Center Utrech	Utrecht
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
United Kingdom	University College of London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent		3 - 6 months	No
Secondary	Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion		6 - 12 months	No
Secondary	Time to recurrent significant dysphagia		6 - 12 months	No
Secondary	Time to dilation of recurrent stricture		6 - 12 months	No
Secondary	6 months and 12 months incidence of repeat dilation		6 - 12 months	No
Secondary	Serious and minor adverse events with possible or likely relation to the study Intervention		6 - 12 months	No
Secondary	Direct medicals costs: procedures, secondary interventions		6 - 12 months	No
Secondary	Quality of Life		6 - 12 months	No
Secondary	Technical success	Observing proper deployment and placement of stent using endoscopic and radiographic imaging.	6 - 12 months	No
Secondary	Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible	Assessment of presence of gold markers within the region of the esophagus at 3 months, using radiographic imaging, if possible, to check for remaining sections of stent that have not yet degraded.	6 - 12 months	No