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WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

This study is currently recruiting participants.
Verified April 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01699542
First received: October 2, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Refractory Anastomotic Esophageal Strictures
 Device: WallFlex Esophageal RX Fully Covered Stent
Device: Esophageal Bougie Dilator Per Investigator preference
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Esophageal Strictures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of procedures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment


Secondary Outcome Measures:
  • Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Technical stent removal success defined as the ability to remove the stent without complications. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient's satisfaction with therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient's report of pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality Of Life (QOL): Improvement in EQ-5D-5L [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient diary to assess dysphagia scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health Economic Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Length of procedures.

  • Health Economic Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of outpatient procedures, office visits and ER

  • Health Economic Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number and length of hospitalizations

  • Title: Health Economic Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of devices used

  • Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Occurrence and severity of adverse events related to the stent/bougie dilator

  • Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to recurrence of dysphagia

  • Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of stent migration

  • Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of reinterventions within 12 months following the initial study treatment.


Estimated Enrollment: 44
Study Start Date: April 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metal Stent
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
 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
Active Comparator: Bougie Dilation
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
 Device: Esophageal Bougie Dilator Per Investigator preference
Commercially available Esophageal Bougie Dilator Per Investigator preference

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699542

Contacts
Contact: Pooja Goswamy 508-683-4335 pooja.goswamy@bsci.com
Contact: Andrea Burbage 508-683-4387 andrea.burbage@bsci.com

Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 05612-000
Contact: Fauze Maluf, MD     551191919014     fauze.maluf@terra.com.br    
Principal Investigator: Fauze Maluf, MD            
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, CE, Netherlands, 3015
Contact: Marco Bruno, MD     310107035946        
Principal Investigator: Marco Bruno, MD            
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Jeanin van Hooft, MD     31205667918     j.e.vanhooft@amc.uva.nl    
Principal Investigator: Jeanin van Hooft, MD            
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584
Contact: Peter D. Siersema, MD     31887559338     p.d.siersema@umcutrecht.nl    
Principal Investigator: Peter D. Siersema, MD            
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Peter D. Siersema, MD Study Principal Investigator
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01699542     History of Changes
Other Study ID Numbers: CDM00049674
Study First Received: October 2, 2012
Last Updated: April 26, 2013
Health Authority: Brazil: ANVISA Approval
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Boston Scientific Corporation:
Refractory Anastomotic esophageal strictures

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Stenosis
Constriction, Pathologic
 Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013