SX ELLA Esophageal Degradable BD Stent System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

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.

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Detailed Description

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Conditions

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Benign Esophageal Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stenting Arm

Group Type EXPERIMENTAL

Stenting with ELLA Biodegradable stent

Intervention Type DEVICE

Treating benign esophageal lesions with the placement of a degradable stent

Dilation Arm

Group Type ACTIVE_COMPARATOR

Standard Dilations

Intervention Type PROCEDURE

Treating benign esophageal lesions with standard dilation therapy

Interventions

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Stenting with ELLA Biodegradable stent

Treating benign esophageal lesions with the placement of a degradable stent

Intervention Type DEVICE

Standard Dilations

Treating benign esophageal lesions with standard dilation therapy

Intervention Type PROCEDURE

Other Intervention Names

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Esophageal Stenting Bougie Dilation, Balloon Dilation

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No