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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal Stent | Active Comparator | The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. |
|
| Bougie Dilation | Active Comparator | Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex Esophageal RX Fully Covered Stent | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dilation Procedures | Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Number of Participants With Technical Stent Removal Success |
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Inclusion Criteria:Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).
Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter.
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| Name | Affiliation | Role |
|---|---|---|
| Peter D. Siersema, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | 05612-000 | Brazil | |||
| Erasmus Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metal Stent | The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. 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 |
| FG001 | Bougie Dilation | Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metal Stent | The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Dilation Procedures | Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment. | Posted | Mean | Standard Deviation | Dilation procedures | 12 months |
|
Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metal Stent | The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Dysphagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Peetermans, PhD - Vice President, Global Clinical Programs | Boston Scientific Corporation | 508-683-4211 | Joyce.Peetermans@bsci.com |
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| Esophageal Bougie Dilator Per Investigator preference | Device | Commercially available Esophageal Bougie Dilator Per Investigator preference |
|
Technical stent removal success is defined as the ability to remove the stent without complications. |
| 12 months |
| 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). | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
| 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). | Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
| 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. | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
| 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. | 12 months |
| Time to Recurrence of Dysphagia | Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture. | 12 months |
| Total Number of Stent Migrations | Total number of stent migrations with or without symptoms. | 12 months |
| Number of Reinterventions Within 12 Months Following the Initial Study Treatment | Number of reinterventions within 12 months following the initial study treatment. | 12 months |
| Rotterdam |
| CE |
| 3015 |
| Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Karolinska Universitets Sjukhuset | Stockholm | S-14186 | Sweden |
| BG001 | Bougie Dilation | Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type of Esophagectomy | Count of Participants | Participants |
|
| Maximum Dilation | Mean | Standard Deviation | mm |
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| Dysphagia Score | Dysphagia Scoring System (scale range from 0 to 4): Dysphagia Score = 0: ability to eat a normal diet Dysphagia Score = 1: ability to eat some solids Dysphagia Score = 2: ability to eat some semisolids only Dysphagia Score = 3: ability to swallow liquids only Dysphagia Score = 4: complete dysphagia A lower score indicates a better outcome. A higher score indicates a worse outcome. | Count of Participants | Participants |
|
| Number of Pretreatment Dilations | Mean | Standard Deviation | Pretreatment Dilations |
|
| Quality of Life Overall Health Score | Quality of life scale measuring overall health score. 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. | Median | Inter-Quartile Range | units on a scale |
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| Secondary | 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. | Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent placement for the Bougie arm. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Technical Stent Removal Success | Technical stent removal success is defined as the ability to remove the stent without complications. | Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent and therefore underwent stent removal. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent removal for the Bougie arm. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 |
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| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
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| Secondary | Time to Recurrence of Dysphagia | Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture. | Posted | Median | Inter-Quartile Range | Days | 12 months |
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| Secondary | Total Number of Stent Migrations | Total number of stent migrations with or without symptoms. | Posted | Number | stent migrations | 12 months |
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| Secondary | Number of Reinterventions Within 12 Months Following the Initial Study Treatment | Number of reinterventions within 12 months following the initial study treatment. | Posted | Mean | Standard Deviation | reinterventions | 12 months |
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| 0 |
| 9 |
| 1 |
| 9 |
| 5 |
| 9 |
| EG001 | Bougie Dilation | Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference | 0 | 9 | 0 | 9 | 0 | 9 |
| Epigastric Pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Gastroesophageal Reflux | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Foreign Body Sensation | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Retching due to Foreign Body Sensation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Thoracic Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Cervical Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
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