Trials / Completed
CompletedNCT01899300
Esophageal Fully Covered Metal Stents in Caustic Strictures Study
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Metal Stent (WallFlex™ Esophageal RX) |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2013-07-15
- Last updated
- 2021-02-12
- Results posted
- 2021-02-12
Locations
2 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01899300. Inclusion in this directory is not an endorsement.