SX ELLA Esophageal Degradable BD Stent System

Cook Group Incorporated66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Esophageal Lesions

Interventions

Stenting with ELLA Biodegradable stentDEVICE

Treating benign esophageal lesions with the placement of a degradable stent

Standard DilationsPROCEDURE

Treating benign esophageal lesions with standard dilation therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (8)

Clinique Universitaire Saint Luc

Brussels, Belgium

University Hospitals Leuven

Leuven, Belgium

IRCCS Istituto Clinico Humanitas

Milan, Italy

Academic Medical Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

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

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

Time frame: 6 - 12 months

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

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.

Data from ClinicalTrials.gov

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