SX ELLA Esophageal Degradable BD Stent System (DESTINY)

Cook Group

Status: Completed

Conditions: Benign Esophageal Lesions

Treatments: Procedure: Standard Dilations; Device: Stenting with ELLA Biodegradable stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337206

09-024

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Stenting Arm

Experimental group

Description:

Stenting Arm

Treatment:

Device: Stenting with ELLA Biodegradable stent

Dilation Arm

Active Comparator group

Description:

Dilation Arm

Treatment:

Procedure: Standard Dilations