Clinical Trial: WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture [ Time Frame: 12 months ]
  • Technical stent removal success defined as the ability to remove the stent without complications. [ Time Frame: 12 months ]
  • Patient's satisfaction with therapy [ Time Frame: 12 months ]
  • Patient's report of pain [ Time Frame: 12 months ]
  • Quality Of Life (QOL): Improvement in EQ-5D-5L [ Time Frame: 12 months ]
  • Patient diary to assess dysphagia scores [ Time Frame: 12 months ]
  • Health Economic Endpoint [ Time Frame: 12 months ]
    Length of procedures.
  • Health Economic Endpoint [ Time Frame: 12 months ]
    Number of outpatient procedures, office visits and ER
  • Health Economic Endpoint [ Time Frame: 12 months ]
    Number and length of hospitalizations
  • Title: Health Economic Endpoint [ Time Frame: 12 months ]
    Number of devices used
  • Safety Endpoint [ Time Frame: 12 months ]
    Occurrence and severity of adverse events related to the stent/bougie dilator
  • Efficacy Endpoint [ Time Frame: 12 months ]
    Time to recurrence of dysphagia
  • Efficacy Endpoint [ Time Frame: 12 months ]
    Incidence of stent migration
  • Efficacy Endpoint [ Time Frame: 12 months ]
    Number of reinterventions within 12 months following the initial study treatment.


Original Secondary Outcome: Same as current

Information By: Boston Scientific Corporation

Dates:
Date Received: October 2, 2012
Date Started: April 2013
Date Completion: September 2016
Last Updated: June 13, 2016
Last Verified: June 2016