Refractory Anastomotic Esophageal StricturesE7025NCT01699542
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
A study testing WallFlex Esophageal RX Fully Covered Stent and Esophageal Bougie Dilator Per Investigator preference in people with Refractory Anastomotic Esophageal Strictures, run by Boston Scientific Corporation at 4 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Anastomotic Esophageal Strictures
- What is being tested?
- WallFlex Esophageal RX Fully Covered Stent and Esophageal Bougie Dilator Per Investigator preference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 23 Dec 2013to 25 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Erasmus Medical Center
Rotterdam, CE, 3015
About this study
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
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
- Being tested
- WallFlex Esophageal RX Fully Covered Stent, Esophageal Bougie Dilator Per Investigator preference
- Keywords
- Refractory Anastomotic esophageal strictures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex Esophageal RX Fully Covered StentDevice
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
Esophageal Bougie Dilator Per Investigator preferenceDevice
Commercially available Esophageal Bougie Dilator Per Investigator preference
| Study group | Role | What they receive |
|---|---|---|
| Metal Stent | Active comparator | The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. Receives: Device: WallFlex Esophageal RX Fully Covered Stent |
| Bougie Dilation | Active comparator | Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. Receives: Device: Esophageal Bougie Dilator Per Investigator preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dilation Procedures
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 12 months
Number of Participants With Technical Stent Removal Success
Technical stent removal success is defined as the ability to remove the stent without complications.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Total Number of Stent Migrations
Total number of stent migrations with or without symptoms.
Measured: 12 months
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Number of reinterventions within 12 months following the initial study treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study start23 Dec 2013
- Primary completion25 Sep 2016
- Study completion25 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Anastomotic Esophageal StricturesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter D. Siersema, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699542
- Sponsor's protocol ID
- 90913904
- Acronym
- E7025
- Status last verified
- Apr 2021
- First submitted
- 2 Oct 2012
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01699542
- Acronym / sponsor ID
- E7025 / 90913904
- Keywords
- Refractory Anastomotic esophageal strictures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2013 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Sep 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 28 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal Stent | Active comparator | Device: WallFlex Esophageal RX Fully Covered StentThe WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures. |
| Bougie Dilation | Active comparator | Device: Esophageal Bougie Dilator Per Investigator preferenceEsophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WallFlex Esophageal RX Fully Covered StentTemporary 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 | Device | Metal Stent |
| Esophageal Bougie Dilator Per Investigator preferenceCommercially available Esophageal Bougie Dilator Per Investigator preference | Device | Bougie Dilation |
Primary outcome
Number of Dilation Procedures
Time frame: 12 months
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
9 secondary outcomes
Number of Participants With Technical Stent Placement Success
Time frame: 12 months
Number of Participants With Technical Stent Removal Success
Time frame: 12 months
Patient's Satisfaction With the Therapy
Time frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Patient's Report of Pain
Time frame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
Quality Of Life Overall Health Score
Time frame: 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
Time frame: 12 months
Time to Recurrence of Dysphagia
Time frame: 12 months
Total Number of Stent Migrations
Time frame: 12 months
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D. Siersema, MD principal investigator
Study Principal Investigator
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex Esophageal RX Fully Covered Stent and Esophageal Bougie Dilator Per Investigator preference in people with Refractory Anastomotic Esophageal Strictures, run by Boston Scientific Corporation at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Brazil, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dilation Procedures (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.