Clinical trial NCT01337206: SX ELLA Esophageal Degradable BD Stent System
Official title: Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Esophageal Lesions
Keywords: Esophageal Stenosis
Esopageal Strictures
Esophageal Dysphagia
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
timeFrame: 3 - 6 months
Secondary outcomes:
measure: Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion
timeFrame: 6 - 12 months
measure: Time to recurrent significant dysphagia
timeFrame: 6 - 12 months
measure: Time to dilation of recurrent stricture
timeFrame: 6 - 12 months
measure: 6 months and 12 months incidence of repeat dilation
timeFrame: 6 - 12 months
measure: Serious and minor adverse events with possible or likely relation to the study Intervention
timeFrame: 6 - 12 months
measure: Direct medicals costs: procedures, secondary interventions
timeFrame: 6 - 12 months
measure: Quality of Life
timeFrame: 6 - 12 months
measure: Technical success
timeFrame: 6 - 12 months
measure: Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Universitaire Saint Luc
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Milan
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrech
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: London
country: United Kingdom
facility: University College of London Hospital
Study officials:
affiliation: University Medical Center Utrech
name: Peter D. Siersema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.