SX ELLA Esophageal Degradable BD Stent System (DESTINY)

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Esophageal Lesions
• Intervention / Treatment: Device: Stenting with ELLA Biodegradable stent; Procedure: Standard Dilations

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Clinique Universitaire Saint Luc
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• Italy
  • Milan, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
• Netherlands
  • Amsterdam, Netherlands, 22700
    • Academic Medical Center
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Utrecht, Netherlands, 3508
    • University Medical Center Utrech
• Spain
  • Ciudad Real, Spain, 13005
    • Hospital General Universitario de Ciudad Real
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College of London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stenting Arm	Device: Stenting with ELLA Biodegradable stent; Treating benign esophageal lesions with the placement of a degradable stent; Other Names: Esophageal Stenting
Active Comparator: Dilation Arm	Procedure: Standard Dilations; Treating benign esophageal lesions with standard dilation therapy; Other Names: Bougie Dilation, Balloon Dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent	3 - 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Direct medicals costs: procedures, secondary interventions		6 - 12 months
Quality of Life		6 - 12 months
Technical success	Observing proper deployment and placement of stent using endoscopic and radiographic imaging.	6 - 12 months
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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Peter D. Siersema, MD, PhD, University Medical Center Utrech

Publications and helpful links

General Publications

• 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. Erratum In: Endoscopy. 2018 Dec;50(12):C12.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Esophageal Stenosis; Esopageal Strictures; Esophageal Dysphagia
• Other Study ID Numbers: 09-024