Benign Esophageal Lesions
Conditions
Keywords
Esophageal Stenosis, Esopageal Strictures, Esophageal Dysphagia
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.
Interventions
DEVICEStenting with ELLA Biodegradable stent
Treating benign esophageal lesions with the placement of a degradable stent
PROCEDUREStandard Dilations
Treating benign esophageal lesions with standard dilation therapy
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent | 3 - 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion | 6 - 12 months | — |
| Quality of Life | 6 - 12 months | — |
| Technical success | 6 - 12 months | Observing proper deployment and placement of stent using endoscopic and radiographic imaging. |
| Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible | 6 - 12 months | 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. |
| Direct medicals costs: procedures, secondary interventions | 6 - 12 months | — |
Countries
Belgium, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed