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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal Stent (WallFlex™ Esophageal RX) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From stent placement on day 0 to 6 months after stent removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Stent placement on Day 0 |
| Stent Removal Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Chandigarh | 160012 | India | |||
| Asian Institute of Gastroenterology |
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Twenty (20) patients with refractory benign esophageal strictures caused by caustic ingestion were planned to be enrolled at 2-4 centers in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metal Stent 8 Week Indwell | Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days |
| FG001 | Metal Stent 12 Week Indwell | Patients 11 to 20 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 12 weeks +/- 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metal Stent 8 Week Indwell | Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days |
| 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, Categorical | Count of Participants |
| 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 | 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. | Posted | Count of Participants | Participants | From stent placement on day 0 to 6 months after stent removal |
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Through completion of study at 32 weeks
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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 8 Week Indwell | Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Gupta, MD | Asian Institute of Gastroenterology | +91 4023378888 | drrajeshgupta98@gmail.com |
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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.
| 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. | 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 | 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
| 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. 0. = ability to eat a normal diet
| 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. | 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 | 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 | 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. | 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. | 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. | From stent placement on Day 0 to end of study at Week 32. |
| Hyderabad |
| 500082 |
| India |
| Participants |
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| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | 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 | Posted | Count of Participants | Participants | Stent placement on Day 0 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Stent removal at Week 8 (±7 days) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | From baseline to stent removal at Week 8 (±7 days) |
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| Secondary | 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 | Pain medication intake data not collected | Posted | From baseline to stent removal at Week 8 (±7 days) |
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| Secondary | 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
| Posted | Mean | Standard Deviation | Score on a scale | From stent placement on day 0 to end of study at Week 32. |
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| Secondary | 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. 0. = ability to eat a normal diet
| Posted | Mean | Standard Deviation | Score on a scale | 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 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | From stent placement on Day 0 to end of study at Week 32 |
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| Secondary | 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 | Posted | Number | Adverse events | From stent placement on Day 0 to end of study at Week 32. |
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| Secondary | 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 | No recurrence of stricture | Posted | From stent placement on Day 0 to end of study at Week 32. |
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| Secondary | 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. | Posted | Number | Stent migrations | From stent placement on Day 0 to end of study at Week 32. |
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| Secondary | 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. | Posted | Number | Kg | From stent placement on Day 0 to end of study at Week 32. |
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| Secondary | 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. | Posted | Number | kg | From stent placement on Day 0 to end of study at Week 32. |
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| 0 |
| 1 |
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