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OpenTrials
Completed

NCT Number: NCT02159898

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).

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Key information

Conditions

Malignant Esophageal Strictures Deglutition Disorders Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Motility Disorders Esophageal Neoplasms Gastroesophageal Reflux Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is 18 years of age or older
  • Patient (or legal representative) is able to understand and provide signed informed consent
  • Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.

Exclusion criteria

  • Patient is unwilling or unable to comply with the follow-up schedule
  • Patient is contraindicated for endoscopic procedure for any reason
  • Patient presents with esophagorespiratory fistula
  • Patient has previously undergone esophageal stenting or esophagectomy
  • Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
  • Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
  • Removal of stent is scheduled to occur within six months
  • Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
  • Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.

Treatment and study plan

EndoMAXX Endoluminal Valve Technology (EVT)

Device

Other names: EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve

EndoMAXX

Device

Other names: EndoMAXX Fully Covered Esophageal Stent

Primary outcomes

  1. Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment

    Time frame: 2 Weeks Following Treatment

    The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment.

    Scale:

    0 = able to eat normal diet / no dysphagia.

    • = able to swallow some solid foods
    • = able to swallow only semi solid foods
    • = able to swallow liquids only
    • = unable to swallow anything / total dysphagia

Secondary outcomes

  1. GERD-HRQL

    Time frame: 4 Weeks Following Treament

    Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment.

    Scale:

    0 = No symptom

    • = Symptoms noticeable but not bothersome
    • = Symptoms noticeable and bothersome but not every day
    • = Symptoms bothersome every day
    • = Symptoms affect daily activity
    • = Symptoms are incapacitating to do daily activities

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Collaborators

  • Geisinger Clinic
  • Indiana University
  • Mayo Clinic
  • Medical College of Wisconsin
  • University of Colorado, Denver
  • University of Florida
  • Weill Medical College of Cornell University

Registry information

Official study title

Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2014
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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