Esophageal Fully Covered Metal Stents in Caustic Strictures Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01899300
First received: June 28, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Stent removal success defined by the ability to remove the stent endoscopically without stent removal related complications. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Stent tolerability defined as completion of planned stent indwell. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Dysphagia score during stent treatment compared to dysphagia score during preceding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to recurrence of stricture, defined as inability of a normal diameter gastroscope (9.8 mm) to pass the stricture. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of stent migration with or without related Adverse Events (AE). [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • Health Economic Endpoint [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Weight gain during stent treatment compared to weight gain during preceding SECSER. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899300

Contacts
Contact: Pooja Goswamy 508-683-4335 pooja.goswamy@bsci.com
Contact: Andrea Burbage 508-683-4387 andrea.burbage@bsci.com

Locations
India
Postgraduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, India, 160012
Contact: Rakesh Kochhar    0172756608    dr_kochhar@hotmail.com   
Principal Investigator: Rakesh Kochhar, MD         
Asian Institute of Gastroenterology Not yet recruiting
Hyderabad, India, 500082
Contact: Rajesh Gupta, MD    4023378888    drrajeshgupta98@gmail.com   
Principal Investigator: Rajesh Gupta, MD         
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01899300     History of Changes
Other Study ID Numbers: 90871111
Study First Received: June 28, 2013
Last Updated: February 4, 2014
Health Authority: India: DCGI

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

ClinicalTrials.gov processed this record on September 18, 2014