Clinical Trial: Esophageal Fully Covered Metal Stents in Caustic Strictures Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ing

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 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. 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.
Sponsor: Boston Scientific Corporation

Current Primary Outcome: Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. [ Time Frame: 9 months ]

Patient ability to tolerate the completion of planned stent indwell and ability to adequately sustain nutrition defined as absence of dysphagia-related reintervention for 6 months after the stent is removed.


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: 9 months ]
  • Stent removal success defined by the ability to remove the stent endoscopically without stent removal related complications. [ Time Frame: 9 months ]
  • Stent tolerability defined as completion of planned stent indwell. [ Time Frame: 9 months ]
  • Patient's Report on Pain compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. [ Time Frame: 9 months ]
  • Change of pain medication intake from Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. [ Time Frame: 9 months ]
  • Improvement of dysphagia score compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Dysphagia score during stent treatment compared to dysphagia score during preceding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER). [ Time Frame: 9 months ]
  • Quality Of Life (QOL) Improvement compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Occurrence and severity 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. [ Time Frame: 9 months ]
  • Time to recurrence of stricture, defined as inability of a normal diameter gastroscope (9.8 mm) to pass the stricture. [ Time Frame: 9 months ]
  • Incidence of stent migration with or without related Adverse Events (AE). [ Time Frame: 9 month ]
  • Health Economic Endpoint [ Time Frame: 9 months ]
    Number of reinterventions from enrollment to end of study, excluding the stent placement and stent removal procedures.
  • Improvement in Patient Weight compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Weight gain during stent treatment compared to weight gain during preceding SECSER. [ Time Frame: 9 months ]


Original Secondary Outcome: Same as current

Information By: Boston Scientific Corporation

Dates:
Date Received: June 28, 2013
Date Started: March 2015
Date Completion:
Last Updated: June 13, 2016
Last Verified: June 2016