Refractory Benign Esophageal Strictures Caused by Caustic IngestionNCT01899300
Esophageal Fully Covered Metal Stents in Caustic Strictures Study
A study testing Metal Stent (WallFlex™ Esophageal RX) in people with Refractory Benign Esophageal Strictures Caused by Caustic Ingestion, run by Boston Scientific Corporation at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
- What is being tested?
- Metal Stent (WallFlex™ Esophageal RX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesIndia
- Study dates
- Mar 2015to Nov 2015
- 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
Who may be able to join
- Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
- Availability of patient history pertaining to weight prior to and at completion of SECSER.
- Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
- Single esophageal stricture or multiple esophageal stricture over a length < 6 cm.
- Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
- Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
Show all 10Show fewer
- 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 (approximately 9.8 mm diameter).
- Age 18 years or older.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Stricture within 2 cm of the upper esophageal sphincter.
- Concomitant Esophageal ulcerations.
- Prior esophageal stent placements.
- Concurrent gastric and/or duodenal obstruction.
- Patients with prior full or partial gastrectomy.
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Asian Institute of Gastroenterology
Hyderabad, 500082
About this study
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 Ingestion
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.
Read the detailed description
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.
- Being tested
- Metal Stent (WallFlex™ Esophageal RX)
- Keywords
- Refractory Benign Esophageal Strictures caused by Caustic Ingestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal Stent (WallFlex™ Esophageal RX)Device
Also called WallFlex™ Esophageal RX Fully Covered Stent
| Study group | Role | What they receive |
|---|---|---|
| Metal Stent | Experimental | The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Receives: Device: Metal Stent (WallFlex™ Esophageal RX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention.
Measured: From stent placement on day 0 to 6 months after stent removal
Secondary outcomes (12)
Stent Placement Success
Number of participants with successful stent placement. Successful stent placement defined as the ability to deploy the stent in satisfactory position across the stricture
Measured: Stent placement on Day 0
Stent Removal Success
Number of participants with successful stent removal. Successful stent removal defined as the ability to remove the stent endoscopically without serious stent removal related complications.
Measured: Stent removal at Week 8 (±7 days)
Change in Patient's Report on Pain Compared to Baseline
Change in Patient's report on pain compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, and Thereafter every 2 weeks until stent removal at Week 8. Pain is reported on the VAS Pain Score scale from 0 (0 being No Pain) to 10 (10 being Worst Pain Ever). Higher score means a worse outcome.
If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: From baseline to stent removal at Week 8 (±7 days)
Change of Pain Medication Intake From Baseline
Change of pain medication intake from baseline at Day2, Week1, Week2, and thereafter every 2 weeks until stent removal
Measured: From baseline to stent removal at Week 8 (±7 days)
Change in Dysphagia Score Compared to Baseline
Change in dysphagia score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. Change value was calculated as dysphagia score measured during stent treatment minus dysphagia score at Baseline.
Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome.
0 = ability to eat a normal diet
- = ability to eat some solids
- = ability to eat some semisolids only
- = ability to swallow liquids only
- = complete dysphagia
Measured: From stent placement on day 0 to end of study at Week 32.
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)
Change in Dysphagia score during stent treatment compared to dysphagia score during proceeding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Change value was calculated as dysphagia score during stent treatment (Day 2, Week 1, Week 2, and thereafter every 2 weeks until end of study at Week 32 minus dysphagia score at SECSER.
Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome.
- = ability to eat a normal diet
- = ability to eat some solids
- = ability to eat some semisolids only
- = ability to swallow liquids only
- = complete dysphagia
Measured: Dysphagia score at SECSER was measured prior to baseline. Dysphagia score during stent treatment was measured from stent placement on day 0 to end of study at Week 32
Change in Quality of Life (QOL) Compared to Baseline
Change in overall Quality of Life (QOL) health score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. QOL Overall Health Score is measured on a scale of 0 to 100, with 0 meaning the worst health you can imagine and 100 meaning the best health you can imagine. Higher score means a better outcome.
Measured: From stent placement on Day 0 to end of study at Week 32
Occurrence of Adverse Events
Occurrence 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
Measured: From stent placement on Day 0 to end of study at Week 32.
Time to Recurrence of Stricture
Time to Recurrence of Stricture, Defined as Inability of a Normal Diameter Gastroscope (9.8 mm) to Pass the Stricture
Measured: From stent placement on Day 0 to end of study at Week 32.
Number of Stent Migration With or Without Related Adverse Events
Number of stent migration with or without Related adverse events (AE). Stent migration is defined as any proximal or distal migration of stent.
Measured: From stent placement on Day 0 to end of study at Week 32.
Change in Patient Weight Compared to Baseline
Change in Patient Weight Compared to Baseline: Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and Thereafter Every 2 Weeks Until End of Study at Week 32. Positive value means increase in weight and negative value means decrease in weight.
Measured: From stent placement on Day 0 to end of study at Week 32.
Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER
Change in patient weight during stent treatment (day 2, week 1, week 2, week 4, week 6, week 8, and thereafter every 2 weeks until end of study at week 32) compared to preceding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Positive value means increase in weight and negative value means decrease in weight.
Measured: From stent placement on Day 0 to end of study at Week 32.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Benign Esophageal Strictures Caused by Caustic IngestionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899300
- Sponsor's protocol ID
- 90871111
- Status last verified
- Jan 2021
- First submitted
- 28 Jun 2013
- Last updated
- 12 Feb 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 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Ingestion
- ClinicalTrials.gov ID
- NCT01899300
- Acronym / sponsor ID
- 90871111
- Keywords
- Refractory Benign Esophageal Strictures caused by Caustic Ingestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Posted 12 Feb 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 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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metal Stent | Experimental | Device: Metal Stent (WallFlex™ Esophageal RX)The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
- Availability of patient history pertaining to weight prior to and at completion of SECSER.
- Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
- Single esophageal stricture or multiple esophageal stricture over a length < 6 cm.
- Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
Key exclusion criteria (8 listed)
- Stricture within 2 cm of the upper esophageal sphincter.
- Concomitant Esophageal ulcerations.
- Prior esophageal stent placements.
- Concurrent gastric and/or duodenal obstruction.
- Patients with prior full or partial gastrectomy.
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 |
|---|---|---|
| Metal Stent (WallFlex™ Esophageal RX)Also: WallFlex™ Esophageal RX Fully Covered Stent | Device | Metal Stent |
Primary outcome
Clinical Success
Time frame: From stent placement on day 0 to 6 months after stent removal
Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention.
12 secondary outcomes
Stent Placement Success
Time frame: Stent placement on Day 0
Stent Removal Success
Time frame: Stent removal at Week 8 (±7 days)
Change in Patient's Report on Pain Compared to Baseline
Time frame: From baseline to stent removal at Week 8 (±7 days)
Change of Pain Medication Intake From Baseline
Time frame: From baseline to stent removal at Week 8 (±7 days)
Change in Dysphagia Score Compared to Baseline
Time frame: From stent placement on day 0 to end of study at Week 32.
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)
Time frame: Dysphagia score at SECSER was measured prior to baseline. Dysphagia score during stent treatment was measured from stent placement on day 0 to end of study at Week 32
Change in Quality of Life (QOL) Compared to Baseline
Time frame: From stent placement on Day 0 to end of study at Week 32
Occurrence of Adverse Events
Time frame: From stent placement on Day 0 to end of study at Week 32.
Time to Recurrence of Stricture
Time frame: From stent placement on Day 0 to end of study at Week 32.
Number of Stent Migration With or Without Related Adverse Events
Time frame: From stent placement on Day 0 to end of study at Week 32.
Change in Patient Weight Compared to Baseline
Time frame: From stent placement on Day 0 to end of study at Week 32.
Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER
Time frame: From stent placement on Day 0 to end of study at Week 32.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metal Stent (WallFlex™ Esophageal RX) in people with Refractory Benign Esophageal Strictures Caused by Caustic Ingestion, run by Boston Scientific Corporation at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 12 Feb 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?
Clinical Success (time frame: From stent placement on day 0 to 6 months after stent removal). 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 12 Feb 2021.