SX ELLA Esophageal Degradable BD Stent System

Study Overview
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Brief Summary
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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.

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

Conditions
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Benign Esophageal Lesions

Intervention / Treatment
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* Device: Stenting with ELLA Biodegradable stent
* Procedure: Standard Dilations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stenting Arm<br>Stenting Arm | Device: Stenting with ELLA Biodegradable stent<br>* Treating benign esophageal lesions with the placement of a degradable stent<br>* Other names: Esophageal Stenting;|
| Active Comparator: Dilation Arm<br>Dilation Arm | Procedure: Standard Dilations<br>* Treating benign esophageal lesions with standard dilation therapy<br>* Other names: Bougie Dilation, Balloon Dilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent |  | 3 - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion |  | 6 - 12 months | 
| Time to recurrent significant dysphagia |  | 6 - 12 months | 
| Time to dilation of recurrent stricture |  | 6 - 12 months | 
| 6 months and 12 months incidence of repeat dilation |  | 6 - 12 months | 
| Serious and minor adverse events with possible or likely relation to the study Intervention |  | 6 - 12 months | 
| Direct medicals costs: procedures, secondary interventions |  | 6 - 12 months | 
| Quality of Life |  | 6 - 12 months | 
| Technical success | Observing proper deployment and placement of stent using endoscopic and radiographic imaging. | 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. | 6 - 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Stenosis, Esopageal Strictures, Esophageal Dysphagia