SX ELLA Esophageal Degradable BD Stent System - Full Text View

Purpose

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.

Condition	Intervention
Benign Esophageal Lesions	Device: Stenting with ELLA Biodegradable stent Procedure: Standard Dilations

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Swallowing Disorders

Drug Information available for: Ulipristal acetate

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:

The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Time to recurrent significant dysphagia [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Time to dilation of recurrent stricture [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
6 months and 12 months incidence of repeat dilation [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Serious and minor adverse events with possible or likely relation to the study Intervention [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Direct medicals costs: procedures, secondary interventions [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Technical success [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	66
Study Start Date:	January 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stenting Arm Stenting Arm	Device: Stenting with ELLA Biodegradable stent Treating benign esophageal lesions with the placement of a degradable stent Other Name: Esophageal Stenting
Active Comparator: Balloon Dilation Arm Balloon Dilation Arm	Procedure: Standard Dilations Treating benign esophageal lesions with standard dilation therapy Other Name: Bougie Dilation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337206

Contacts

Contact: Malin Tygesen

45 202 325 72

Malin.Tygesen@CookMedical.com

Locations

Belgium
Clinique Universitaire Saint Luc	Recruiting
Brussels, Belgium, 1000
Contact: Pierre Deprez +32 4758 92185 deprez@gaen.ucl.ac.be
University Hospitals Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Raf Bisschops +32 16 34 69 00
Italy
IRCCS Istituto Clinico Humanitas	Recruiting
Milan, Italy, 20089
Contact: Alessandro Repici +393346696665 alessandro.repici@humanitas.it
Netherlands
Academic Medical Center	Recruiting
Amsterdam, Netherlands, 22700
Contact: Jeanin van Hooft +31 20 566 9111
St. Antonius Hospital	Not yet recruiting
Nieuwegein, Netherlands
Contact: Bas Weusten, MD b.weusten@antoniusziekenhuis.nl
University Medical Center Utrech	Recruiting
Utrecht, Netherlands, 3508
Contact: Frank Vleggaar +31 088 75 55555 f.vleggaar@umcutrecht.nl
Spain
Hospital General Universitario de Ciudad Real	Recruiting
Ciudad Real, Spain, 13005
Contact: Bartolome L. Viedma +35 36569987425 bnngranada@gmail.com
United Kingdom
University College of London Hospital	Recruiting
London, United Kingdom, NW1 2PG
Contact: Laurence Lovat +34 0845155 5000

Sponsors and Collaborators

Cook

Investigators

Principal Investigator:

Peter D. Siersema, MD, PhD

University Medical Center Utrech

More Information

No publications provided

Responsible Party:	Cook
ClinicalTrials.gov Identifier:	NCT01337206 History of Changes
Other Study ID Numbers:	09-024
Study First Received:	April 13, 2011
Last Updated:	March 8, 2013
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Cook:

Esophageal Stenosis
Esopageal Strictures
Esophageal Dysphagia

Additional relevant MeSH terms:

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

SX ELLA Esophageal Degradable BD Stent System (DESTINY)