Esophageal Fully Covered Metal Stents in Caustic Strictures Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Detailed Description
-----------------
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Also to collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Official Title
-----------------
A Multi-Center, Prospective, Evaluation of the Use of a Fully Covered Metal Stent (FCMS) for the Treatment of Refractory Benign Esophageal Strictures Caused by Caustic Ingestion

Conditions
-----------------
Refractory Benign Esophageal Strictures Caused by Caustic Ingestion

Intervention / Treatment
-----------------
* Device: Metal Stent (WallFlex™ Esophageal RX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER. Availability of patient history pertaining to weight prior to and at completion of SECSER. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment. Single esophageal stricture or multiple esophageal stricture over a length < 6 cm. Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline. Unable to pass a standard endoscope (approximately 9.8 mm diameter). Age 18 years or older. Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Stricture within 2 cm of the upper esophageal sphincter. Concomitant Esophageal ulcerations. Prior esophageal stent placements. Concurrent gastric and/or duodenal obstruction. Patients with prior full or partial gastrectomy. Sensitivity to any components of the stent or delivery system. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metal Stent<br>The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. | Device: Metal Stent (WallFlex™ Esophageal RX)<br> <br> * Other names: WallFlex™ Esophageal RX Fully Covered Stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention. | From stent placement on day 0 to 6 months after stent removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Placement Success | Number of participants with successful stent placement. Successful stent placement defined as the ability to deploy the stent in satisfactory position across the stricture | Stent placement on Day 0 | 
| Stent Removal Success | Number of participants with successful stent removal. Successful stent removal defined as the ability to remove the stent endoscopically without serious stent removal related complications. | Stent removal at Week 8 (±7 days) | 
| Change in Patient's Report on Pain Compared to Baseline | Change in Patient's report on pain compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, and Thereafter every 2 weeks until stent removal at Week 8. Pain is reported on the VAS Pain Score scale from 0 (0 being No Pain) to 10 (10 being Worst Pain Ever). Higher score means a worse outcome. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. | From baseline to stent removal at Week 8 (±7 days) | 
| Change of Pain Medication Intake From Baseline | Change of pain medication intake from baseline at Day2, Week1, Week2, and thereafter every 2 weeks until stent removal | From baseline to stent removal at Week 8 (±7 days) | 
| Change in Dysphagia Score Compared to Baseline | Change in dysphagia score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. Change value was calculated as dysphagia score measured during stent treatment minus dysphagia score at Baseline. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0 = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia | From stent placement on day 0 to end of study at Week 32. | 
| Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Change in Dysphagia score during stent treatment compared to dysphagia score during proceeding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Change value was calculated as dysphagia score during stent treatment (Day 2, Week 1, Week 2, and thereafter every 2 weeks until end of study at Week 32 minus dysphagia score at SECSER. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0. = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia | Dysphagia score at SECSER was measured prior to baseline. Dysphagia score during stent treatment was measured from stent placement on day 0 to end of study at Week 32 | 
| Change in Quality of Life (QOL) Compared to Baseline | Change in overall Quality of Life (QOL) health score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. QOL Overall Health Score is measured on a scale of 0 to 100, with 0 meaning the worst health you can imagine and 100 meaning the best health you can imagine. Higher score means a better outcome. | From stent placement on Day 0 to end of study at Week 32 | 
| Occurrence of Adverse Events | Occurrence of Adverse Events Related to the Stent and/or the Stent Placement or Stent Removal Procedure and of All Serious Adverse Events Throughout the Duration of the Study | From stent placement on Day 0 to end of study at Week 32. | 
| Time to Recurrence of Stricture | Time to Recurrence of Stricture, Defined as Inability of a Normal Diameter Gastroscope (9.8 mm) to Pass the Stricture | From stent placement on Day 0 to end of study at Week 32. | 
| Number of Stent Migration With or Without Related Adverse Events | Number of stent migration with or without Related adverse events (AE). Stent migration is defined as any proximal or distal migration of stent. | From stent placement on Day 0 to end of study at Week 32. | 
| Change in Patient Weight Compared to Baseline | Change in Patient Weight Compared to Baseline: Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and Thereafter Every 2 Weeks Until End of Study at Week 32. Positive value means increase in weight and negative value means decrease in weight. | From stent placement on Day 0 to end of study at Week 32. | 
| Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Change in patient weight during stent treatment (day 2, week 1, week 2, week 4, week 6, week 8, and thereafter every 2 weeks until end of study at week 32) compared to preceding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Positive value means increase in weight and negative value means decrease in weight. | From stent placement on Day 0 to end of study at Week 32. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Benign Esophageal Strictures caused by Caustic Ingestion