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OpenTrials
Completed

NCT Number: NCT01337206

SX ELLA Esophageal Degradable BD 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.

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Key information

Conditions

Benign Esophageal Lesions Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Stenosis Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Universitaire Saint Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stenting with ELLA Biodegradable stent

Device

Treating benign esophageal lesions with the placement of a degradable stent

Other names: Esophageal Stenting

Standard Dilations

Procedure

Treating benign esophageal lesions with standard dilation therapy

Other names: Bougie Dilation, Balloon Dilation

Primary outcomes

  1. The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent

    Time frame: 3 - 6 months

Secondary outcomes

  1. Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion

    Time frame: 6 - 12 months

  2. Time to recurrent significant dysphagia

    Time frame: 6 - 12 months

  3. Time to dilation of recurrent stricture

    Time frame: 6 - 12 months

  4. 6 months and 12 months incidence of repeat dilation

    Time frame: 6 - 12 months

  5. Serious and minor adverse events with possible or likely relation to the study Intervention

    Time frame: 6 - 12 months

  6. Direct medicals costs: procedures, secondary interventions

    Time frame: 6 - 12 months

  7. Quality of Life

    Time frame: 6 - 12 months

  8. Technical success

    Time frame: 6 - 12 months

    Observing proper deployment and placement of stent using endoscopic and radiographic imaging.

  9. 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.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Acronym: DESTINY

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 18, 2011
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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