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WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture (E7025)

Primary Purpose

Refractory Anastomotic Esophageal Strictures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WallFlex Esophageal RX Fully Covered Stent
Esophageal Bougie Dilator Per Investigator preference
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Anastomotic Esophageal Strictures focused on measuring Refractory Anastomotic esophageal strictures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto do Cancer do Estado de Sao Paulo
  • Erasmus Medical Center
  • Academisch Medisch Centrum
  • Karolinska Universitets Sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metal Stent

Bougie Dilation

Arm Description

The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.

Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Technical Stent Placement Success
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
Technical stent removal success is defined as the ability to remove the stent without complications.
Patient's Satisfaction With the Therapy
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
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
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
Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
Time to Recurrence of Dysphagia
Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
Total Number of Stent Migrations
Total number of stent migrations with or without symptoms.
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Number of reinterventions within 12 months following the initial study treatment.

Full Information

First Posted
October 2, 2012
Last Updated
June 4, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01699542
Brief Title
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
Acronym
E7025
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2013 (Actual)
Primary Completion Date
September 25, 2016 (Actual)
Study Completion Date
September 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Anastomotic Esophageal Strictures
Keywords
Refractory Anastomotic esophageal strictures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metal Stent
Arm Type
Active Comparator
Arm Description
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
Arm Title
Bougie Dilation
Arm Type
Active Comparator
Arm Description
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Intervention Type
Device
Intervention Name(s)
WallFlex Esophageal RX Fully Covered Stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Esophageal Bougie Dilator Per Investigator preference
Intervention Description
Commercially available Esophageal Bougie Dilator Per Investigator preference
Primary Outcome Measure Information:
Title
Number of Dilation Procedures
Description
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Technical Stent Placement Success
Description
Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
Time Frame
12 months
Title
Number of Participants With Technical Stent Removal Success
Description
Technical stent removal success is defined as the ability to remove the stent without complications.
Time Frame
12 months
Title
Patient's Satisfaction With the Therapy
Description
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).
Time Frame
Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Title
Patient's Report of Pain
Description
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).
Time Frame
Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Title
Quality Of Life Overall Health Score
Description
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.
Time Frame
Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Title
Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
Description
Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
Time Frame
12 months
Title
Time to Recurrence of Dysphagia
Description
Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
Time Frame
12 months
Title
Total Number of Stent Migrations
Description
Total number of stent migrations with or without symptoms.
Time Frame
12 months
Title
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Description
Number of reinterventions within 12 months following the initial study treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D. Siersema, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05612-000
Country
Brazil
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
CE
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Karolinska Universitets Sjukhuset
City
Stockholm
ZIP/Postal Code
S-14186
Country
Sweden

12. IPD Sharing Statement

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WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

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