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SX ELLA Esophageal Degradable BD Stent System

Information source: Cook
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Esophageal Lesions

Intervention: Stenting with ELLA Biodegradable stent (Device); Standard Dilations (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Cook

Official(s) and/or principal investigator(s):
Peter D. Siersema, MD, PhD, Principal Investigator, Affiliation: University Medical Center Utrech

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent

Secondary outcome:

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

Time to recurrent significant dysphagia

Time to dilation of recurrent stricture

6 months and 12 months incidence of repeat dilation

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

Direct medicals costs: procedures, secondary interventions

Quality of Life

Technical success

Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Clinique Universitaire Saint Luc, Brussels 1000, Belgium

University Hospitals Leuven, Leuven 3000, Belgium

IRCCS Istituto Clinico Humanitas, Milan 20089, Italy

Academic Medical Center, Amsterdam 22700, Netherlands

St. Antonius Hospital, Nieuwegein, Netherlands

University Medical Center Utrech, Utrecht 3508, Netherlands

Hospital General Universitario de Ciudad Real, Ciudad Real 13005, Spain

University College of London Hospital, London NW1 2PG, United Kingdom

Additional Information

Starting date: January 2012
Last updated: February 5, 2015

Page last updated: August 20, 2015

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