---
title: SX ELLA Esophageal Degradable BD Stent System
nct_id: NCT01337206
overall_status: COMPLETED
phase: NA
sponsor: Cook Group Incorporated
study_type: INTERVENTIONAL
primary_condition: Benign Esophageal Lesions
countries: Belgium, Italy, Netherlands, Spain, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01337206.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01337206"
ct_last_update_post_date: 2015-02-06
last_seen_at: "2026-05-12T06:40:54.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SX ELLA Esophageal Degradable BD Stent System

**Official Title:** Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System

**NCT ID:** [NCT01337206](https://clinicaltrials.gov/study/NCT01337206)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** Cook Group Incorporated
- **Conditions:** Benign Esophageal Lesions
- **Start Date:** 2012-01
- **Completion Date:** 2015-01
- **CT.gov Last Update:** 2015-02-06

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Stenting Arm** (EXPERIMENTAL) — Stenting Arm
- **Dilation Arm** (ACTIVE_COMPARATOR) — Dilation Arm

## Interventions

- **Stenting with ELLA Biodegradable stent** (DEVICE) — Treating benign esophageal lesions with the placement of a degradable stent
- **Standard Dilations** (PROCEDURE) — Treating benign esophageal lesions with standard dilation therapy

## Primary Outcomes

- **The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent** _(time frame: 3 - 6 months)_

## Secondary Outcomes

- **Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion** _(time frame: 6 - 12 months)_
- **Time to recurrent significant dysphagia** _(time frame: 6 - 12 months)_
- **Time to dilation of recurrent stricture** _(time frame: 6 - 12 months)_
- **6 months and 12 months incidence of repeat dilation** _(time frame: 6 - 12 months)_
- **Serious and minor adverse events with possible or likely relation to the study Intervention** _(time frame: 6 - 12 months)_
- **Direct medicals costs: procedures, secondary interventions** _(time frame: 6 - 12 months)_
- **Quality of Life** _(time frame: 6 - 12 months)_
- **Technical success** _(time frame: 6 - 12 months)_
- **Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible** _(time frame: 6 - 12 months)_

## Locations (8)

- Clinique Universitaire Saint Luc, Brussels, Belgium
- University Hospitals Leuven, Leuven, Belgium
- IRCCS Istituto Clinico Humanitas, Milan, Italy
- Academic Medical Center, Amsterdam, Netherlands
- St. Antonius Hospital, Nieuwegein, Netherlands
- University Medical Center Utrech, Utrecht, Netherlands
- Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
- University College of London Hospital, London, United Kingdom

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinique universitaire saint luc|brussels||belgium` — added _(2026-05-12)_
- `locations.university hospitals leuven|leuven||belgium` — added _(2026-05-12)_
- `locations.irccs istituto clinico humanitas|milan||italy` — added _(2026-05-12)_
- `locations.academic medical center|amsterdam||netherlands` — added _(2026-05-12)_
- `locations.st. antonius hospital|nieuwegein||netherlands` — added _(2026-05-12)_
- `locations.university medical center utrech|utrecht||netherlands` — added _(2026-05-12)_
- `locations.hospital general universitario de ciudad real|ciudad real||spain` — added _(2026-05-12)_
- `locations.university college of london hospital|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01337206.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01337206*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*