CompletedNot Applicable

SX ELLA Esophageal Degradable BD Stent System

Belgium, Italy, Netherlands66 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 3 - 6 months

Trial details

NCT IDNCT01337206

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Benign Esophageal Lesions trials