Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
Conditions
Keywords
Refractory Benign Esophageal Strictures caused by Caustic Ingestion
Brief 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.
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.
Interventions
DEVICEMetal Stent (WallFlex™ Esophageal RX)
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER. 2. Availability of patient history pertaining to weight prior to and at completion of SECSER. 3. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment. 4. Single esophageal stricture or multiple esophageal stricture over a length \< 6 cm. 5. 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. 6. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER. 7. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline. 8. Unable to pass a standard endoscope (approximately 9.8 mm diameter). 9. Age 18 years or older. 10. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
1. Stricture within 2 cm of the upper esophageal sphincter. 2. Concomitant Esophageal ulcerations. 3. Prior esophageal stent placements. 4. Concurrent gastric and/or duodenal obstruction. 5. Patients with prior full or partial gastrectomy. 6. Sensitivity to any components of the stent or delivery system. 7. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. 8. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Removal Success | Stent removal at Week 8 (±7 days) | 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. |
| Change in Patient's Report on Pain Compared to Baseline | From baseline to stent removal at Week 8 (±7 days) | 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. |
| Change of Pain Medication Intake From Baseline | From baseline to stent removal at Week 8 (±7 days) | Change of pain medication intake from baseline at Day2, Week1, Week2, and thereafter every 2 weeks until stent removal |
| Change in Dysphagia Score Compared to Baseline | From stent placement on day 0 to end of study at Week 32. | 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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia |
| Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | 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 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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia |
| Stent Placement Success | Stent placement on Day 0 | Number of participants with successful stent placement. Successful stent placement defined as the ability to deploy the stent in satisfactory position across the stricture |
| Occurrence of Adverse Events | From stent placement on Day 0 to end of study at Week 32. | 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 |
| Time to Recurrence of Stricture | From stent placement on Day 0 to end of study at Week 32. | Time to Recurrence of Stricture, Defined as Inability of a Normal Diameter Gastroscope (9.8 mm) to Pass the Stricture |
| Number of Stent Migration With or Without Related Adverse Events | From stent placement on Day 0 to end of study at Week 32. | Number of stent migration with or without Related adverse events (AE). Stent migration is defined as any proximal or distal migration of stent. |
| Change in Patient Weight Compared to Baseline | From stent placement on Day 0 to end of study at Week 32. | 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. |
| Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | From stent placement on Day 0 to end of study at Week 32. | 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. |
| Change in Quality of Life (QOL) Compared to Baseline | From stent placement on Day 0 to end of study at Week 32 | 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. |
Countries
India
Participant flow
Recruitment details
Twenty (20) patients with refractory benign esophageal strictures caused by caustic ingestion were planned to be enrolled at 2-4 centers in India. * Group 1: Patients 1-10, stent indwell for 8 weeks +/- 7 days. * Group 2: Patients 11-20, stent indwell for 12 weeks +/- 7 days.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Metal Stent 8 Week Indwell |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 54 Years |
| Region of Enrollment India | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: From stent placement on day 0 to 6 months after stent removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metal Stent 8 Week Indwell | Clinical Success | 1 Participants |
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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia
Time frame: From stent placement on day 0 to end of study at Week 32.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Day2 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 1 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 2 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 4 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 6 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 8 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 10 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 12 vs Baseline | 0 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 14 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 16 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 18 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 20 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 22 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 24 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 28 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 30 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 32 vs Baseline | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Dysphagia Score Compared to Baseline | Week 26 vs Baseline | -1 Score on a scale |
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.
Time frame: From baseline to stent removal at Week 8 (±7 days)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Day 2 vs Baseline | 0 score on a scale |
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Week 1 vs Baseline | 1 score on a scale |
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Week 2 vs Baseline | 0 score on a scale |
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Week 4 vs Baseline | 1 score on a scale |
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Week 6 vs Baseline | 1 score on a scale |
| Metal Stent 8 Week Indwell | Change in Patient's Report on Pain Compared to Baseline | Week 8 vs Baseline | 0 score on a scale |
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.
Time frame: From stent placement on Day 0 to end of study at Week 32.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Day 2 vs Baseline | 0 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 1 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 2 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 4 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 6 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 8 vs Baseline | 0 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 10 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 12 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 14 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 16 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 18 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 20 vs Baseline | 0 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 22 vs Baseline | 0 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 24 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 26 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 28 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 30 vs Baseline | -1 Kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight Compared to Baseline | Week 32 vs Baseline | -1 Kg |
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.
Time frame: From stent placement on Day 0 to end of study at Week 32.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Day2 vs SECSR | 1 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 1 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 2 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 4 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 6 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 8 vs SECSR | 1 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 10 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 12 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 14 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 16 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 18 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 20 vs SECSR | 1 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 22 vs SECSR | 1 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 24 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 26 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 28 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 30 vs SECSR | 0 kg |
| Metal Stent 8 Week Indwell | Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER | Week 32 vs SECSR | 0 kg |
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.
Time frame: From stent placement on Day 0 to end of study at Week 32
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 30 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 32 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Day 2 vs Baseline | 5 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 1 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 2 vs Baseline | 20 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 4 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 6 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 8 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 10 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 12 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 14 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 16 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 18 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 20 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 22 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 24 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 26 vs Baseline | 10 Score on a scale |
| Metal Stent 8 Week Indwell | Change in Quality of Life (QOL) Compared to Baseline | Week 28 vs Baseline | 10 Score on a scale |
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
Time frame: From baseline to stent removal at Week 8 (±7 days)
Population: Pain medication intake data not collected
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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Day2 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 1 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 2 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 4 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 6 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 12 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 14 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 16 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 18 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 20 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 22 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 24 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 26 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 28 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 30 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 32 vs SECSR | -2 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 8 vs SECSR | -1 Score on a scale |
| Metal Stent 8 Week Indwell | Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) | Week 10 vs SECSR | -1 Score on a scale |
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.
Time frame: From stent placement on Day 0 to end of study at Week 32.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metal Stent 8 Week Indwell | Number of Stent Migration With or Without Related Adverse Events | 0 Stent migrations |
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
Time frame: From stent placement on Day 0 to end of study at Week 32.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metal Stent 8 Week Indwell | Occurrence of Adverse Events | 0 Adverse events |
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
Time frame: Stent placement on Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metal Stent 8 Week Indwell | Stent Placement Success | 1 Participants |
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.
Time frame: Stent removal at Week 8 (±7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metal Stent 8 Week Indwell | Stent Removal Success | 1 Participants |
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
Time frame: From stent placement on Day 0 to end of study at Week 32.
Population: No recurrence of stricture