Overview

This trial is active, not recruiting.

Condition malignant esophageal strictures
Treatments endomaxx evt, endomaxx
Phase phase 3
Sponsor Merit Medical Systems, Inc.
Collaborator Geisinger Clinic
Start date January 2015
End date November 2016
Trial size 60 participants
Trial identifier NCT02159898, ESO-P3-12-02

Summary

This is a prospective, single blinded, randomized study of EndoMAXX 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 EVT Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
EndoMAXX EVT Fully Covered Esophageal Stent with Valve
endomaxx evt EndoMAXX EVT Fully Covered Esophageal Stent with Valve
(Active Comparator)
EndoMAXX Fully Covered Esophageal Stent
endomaxx EndoMAXX Fully Covered Esophageal Stent

Primary Outcomes

Measure
Mellow and Pinkas Dysphagia Score
time frame: 2 Weeks Following Treatment

Secondary Outcomes

Measure
GERD-HRQL
time frame: 4 Weeks Following Treament
Regurgitation Questionnaire
time frame: 4 Weeks Following Treatment
Safety
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient is 18 years of age or older 2. Patient (or legal representative) is able to understand and provide signed informed consent 3. Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction. Exclusion Criteria: 1. Patient is unwilling or unable to comply with the follow-up schedule 2. Patient is contraindicated for endoscopic procedure for any reason 3. Patient presents with esophagorespiratory fistula 4. Patient has previously undergone esophageal stenting or esophagectomy 5. Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception 6. Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm) 7. Removal of stent is scheduled to occur within six months 8. Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer 9. 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.

Additional Information

Official title Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX EVT Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction
Principal investigator Kulwinder DUA, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merit Medical Systems, Inc..