N/A
N=1
Esophageal Fully Covered Metal Stents in Caustic Strictures Study
Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
Bottom Line
View on ClinicalTrials.gov: NCT01899300 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Success — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metal Stent (WallFlex™ Esophageal RX) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success |
1 | — |
| SECONDARY Stent Placement Success |
1 | — |
| SECONDARY Stent Removal Success |
1 | — |
| SECONDARY Change in Patient's Report on Pain Compared to Baseline |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Change of Pain Medication Intake From Baseline |
— | — |
| SECONDARY Change in Dysphagia Score Compared to Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) |
-1; -1; -1; -1; -1; -1 | — |
| SECONDARY Change in Quality of Life (QOL) Compared to Baseline |
5; 10; 20; 10; 10; 10 | — |
| SECONDARY Occurrence of Adverse Events |
— | — |
| SECONDARY Time to Recurrence of Stricture |
— | — |
| SECONDARY Number of Stent Migration With or Without Related Adverse Events |
— | — |
| SECONDARY Change in Patient Weight Compared to Baseline |
0; -1; -1; -1; -1; 0 | — |
| SECONDARY Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER |
1; 0; 0; 0; 0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01899300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.