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Esophageal Fully Covered Metal Stents in Caustic Strictures Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899300
First Posted: July 15, 2013
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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.

Condition Intervention Phase
Refractory Benign Esophageal Strictures Caused by Caustic Ingestion Device: Metal Stent (WallFlex™ Esophageal RX) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. [ Time Frame: 9 months ]
    Patient ability to tolerate the completion of planned stent indwell and ability to adequately sustain nutrition defined as absence of dysphagia-related reintervention for 6 months after the stent is removed.


Secondary Outcome Measures:
  • Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture. [ Time Frame: 9 months ]
  • Stent removal success defined by the ability to remove the stent endoscopically without stent removal related complications. [ Time Frame: 9 months ]
  • Stent tolerability defined as completion of planned stent indwell. [ Time Frame: 9 months ]
  • Patient's Report on Pain compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. [ Time Frame: 9 months ]
  • Change of pain medication intake from Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. [ Time Frame: 9 months ]
  • Improvement of dysphagia score compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Dysphagia score during stent treatment compared to dysphagia score during preceding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER). [ Time Frame: 9 months ]
  • Quality Of Life (QOL) Improvement compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Occurrence and severity 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: 9 months ]
  • Time to recurrence of stricture, defined as inability of a normal diameter gastroscope (9.8 mm) to pass the stricture. [ Time Frame: 9 months ]
  • Incidence of stent migration with or without related Adverse Events (AE). [ Time Frame: 9 month ]
  • Health Economic Endpoint [ Time Frame: 9 months ]
    Number of reinterventions from enrollment to end of study, excluding the stent placement and stent removal procedures.

  • Improvement in Patient Weight compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. [ Time Frame: 9 months ]
  • Weight gain during stent treatment compared to weight gain during preceding SECSER. [ Time Frame: 9 months ]

Enrollment: 1
Study Start Date: March 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metal Stent
The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.
Device: Metal Stent (WallFlex™ Esophageal RX)
Other Name: WallFlex™ Esophageal RX Fully Covered Stent

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899300


Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Asian Institute of Gastroenterology
Hyderabad, India, 500082
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01899300     History of Changes
Other Study ID Numbers: 90871111
First Submitted: June 28, 2013
First Posted: July 15, 2013
Last Update Posted: November 15, 2017
Last Verified: June 2016

Keywords provided by Boston Scientific Corporation:
Refractory Benign Esophageal Strictures caused by Caustic Ingestion

Additional relevant MeSH terms:
Constriction, Pathologic
Esophageal Stenosis
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases