SX ELLA Esophageal Degradable BD Stent System

Not Applicable

Completed

• Conditions: Benign Esophageal Lesions
• Interventions: Procedure: Standard Dilations; Device: Stenting with ELLA Biodegradable stent

• Registration Number: NCT01337206
• Lead Sponsor: Cook Group Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Study Start: 2012-01
• Primary Completion: 2014-07
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilation Arm	Standard Dilations	Dilation Arm
Stenting Arm	Stenting with ELLA Biodegradable stent	Stenting Arm

Primary Outcome Measures

Name	Time	Method
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent	3 - 6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion	6 - 12 months
Time to dilation of recurrent stricture	6 - 12 months
Serious and minor adverse events with possible or likely relation to the study Intervention	6 - 12 months
Time to recurrent significant dysphagia	6 - 12 months
Direct medicals costs: procedures, secondary interventions	6 - 12 months
Quality of Life	6 - 12 months
6 months and 12 months incidence of repeat dilation	6 - 12 months
Technical success	6 - 12 months	Observing proper deployment and placement of stent using endoscopic and radiographic imaging.
Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible	6 - 12 months	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.

Trial Locations

Locations (8)

Clinique Universitaire Saint Luc; 🇧🇪 Brussels, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

IRCCS Istituto Clinico Humanitas; 🇮🇹 Milan, Italy

University Medical Center Utrech; 🇳🇱 Utrecht, Netherlands

University College of London Hospital; 🇬🇧 London, United Kingdom

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain