EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Malignant Esophageal Strictures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EndoMAXX Endoluminal Valve Technology (EVT)

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

Group Type EXPERIMENTAL

EndoMAXX Endoluminal Valve Technology (EVT)

Intervention Type DEVICE

EndoMAXX

EndoMAXX Fully Covered Esophageal Stent

Group Type ACTIVE_COMPARATOR

EndoMAXX

Intervention Type DEVICE

Interventions

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EndoMAXX Endoluminal Valve Technology (EVT)

Intervention Type DEVICE

EndoMAXX

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No