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SX ELLA Esophageal Degradable BD Stent System (DESTINY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337206
First Posted: April 18, 2011
Last Update Posted: February 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  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: None (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:


Further study details as provided by Cook Group Incorporated:

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 ]

Secondary Outcome Measures:
  • Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion [ Time Frame: 6 - 12 months ]
  • Time to recurrent significant dysphagia [ Time Frame: 6 - 12 months ]
  • Time to dilation of recurrent stricture [ Time Frame: 6 - 12 months ]
  • 6 months and 12 months incidence of repeat dilation [ Time Frame: 6 - 12 months ]
  • Serious and minor adverse events with possible or likely relation to the study Intervention [ Time Frame: 6 - 12 months ]
  • Direct medicals costs: procedures, secondary interventions [ Time Frame: 6 - 12 months ]
  • Quality of Life [ Time Frame: 6 - 12 months ]
  • Technical success [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 66
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: July 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: Dilation Arm
Dilation Arm
Procedure: Standard Dilations
Treating benign esophageal lesions with standard dilation therapy
Other Name: Bougie Dilation, Balloon Dilation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337206


Locations
Belgium
Clinique Universitaire Saint Luc
Brussels, Belgium, 1000
University Hospitals Leuven
Leuven, Belgium, 3000
Italy
IRCCS Istituto Clinico Humanitas
Milan, Italy, 20089
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 22700
St. Antonius Hospital
Nieuwegein, Netherlands
University Medical Center Utrech
Utrecht, Netherlands, 3508
Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
United Kingdom
University College of London Hospital
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Peter D. Siersema, MD, PhD University Medical Center Utrech
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01337206     History of Changes
Other Study ID Numbers: 09-024
First Submitted: April 13, 2011
First Posted: April 18, 2011
Last Update Posted: February 6, 2015
Last Verified: February 2015

Keywords provided by Cook Group Incorporated:
Esophageal Stenosis
Esopageal Strictures
Esophageal Dysphagia