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SX ELLA Esophageal Degradable BD Stent System

NCT01337206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-02-06

No results posted yet for this study

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.

Conditions

  • Benign Esophageal Lesions

Interventions

DEVICE

Stenting with ELLA Biodegradable stent

Treating benign esophageal lesions with the placement of a degradable stent

PROCEDURE

Standard Dilations

Treating benign esophageal lesions with standard dilation therapy

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Peter D. Siersema, MD, PhD · University Medical Center Utrech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-07-31
Completion
2015-01-31

Countries

  • Belgium
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337206 on ClinicalTrials.gov