SX ELLA Esophageal Degradable BD Stent System (DESTINY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01337206
First received: April 13, 2011
Last updated: February 12, 2014
Last verified: February 2014
  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:


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: January 2015
Estimated Primary Completion Date: January 2015 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: February 12, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Cook:
Esophageal Stenosis
Esopageal Strictures
Esophageal Dysphagia

ClinicalTrials.gov processed this record on October 19, 2014