WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

Overview

The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures

Full Title of Study: “A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 25, 2016

Interventions

  • Device: WallFlex Esophageal RX Fully Covered Stent
    • Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
  • Device: Esophageal Bougie Dilator Per Investigator preference
    • Commercially available Esophageal Bougie Dilator Per Investigator preference

Arms, Groups and Cohorts

  • Active Comparator: Metal Stent
    • The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
  • Active Comparator: Bougie Dilation
    • Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Dilation Procedures
    • Time Frame: 12 months
    • Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.

Secondary Measures

  • Number of Participants With Technical Stent Placement Success
    • Time Frame: 12 months
    • Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
  • Number of Participants With Technical Stent Removal Success
    • Time Frame: 12 months
    • Technical stent removal success is defined as the ability to remove the stent without complications.
  • Patient’s Satisfaction With the Therapy
    • Time Frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
    • Patient’s satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).
  • Patient’s Report of Pain
    • Time Frame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
    • Patient’s report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).
  • Quality Of Life Overall Health Score
    • Time Frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
    • Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.
  • Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
    • Time Frame: 12 months
    • Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
  • Time to Recurrence of Dysphagia
    • Time Frame: 12 months
    • Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
  • Total Number of Stent Migrations
    • Time Frame: 12 months
    • Total number of stent migrations with or without symptoms.
  • Number of Reinterventions Within 12 Months Following the Initial Study Treatment
    • Time Frame: 12 months
    • Number of reinterventions within 12 months following the initial study treatment.

Participating in This Clinical Trial

Inclusion Criteria

Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).

  • Esophagectomy performed at the same institution where patient enrollment and follow-up is planned. – Two dilations to at least 16 mm in diameter since esophagectomy. – 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm. – 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 (approx. 9.8 mm diameter). – Age 18 years or older. – Willing and able to comply with the study procedures and provide Exclusion Criteria:

Stricture within 2 cm of the upper esophageal sphincter.

  • Dysphagia related to motility disorder. – Non-anastomotic esophageal strictures. – Esophagocolonic strictures. – Planned adjuvant radiation therapy post esophagectomy. – Prior esophageal stent placements post esophagectomy. – Active erosive esophagitis. – 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. – Stricture length > 5 cm.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boston Scientific Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter D. Siersema, MD, Principal Investigator, Study Principal Investigator

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