EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Merit Medical Systems

Status: Completed

Conditions: Malignant Esophageal Strictures

Treatments: Device: EndoMAXX; Device: EndoMAXX Endoluminal Valve Technology (EVT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02159898

ESO-P3-12-02

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

EndoMAXX Endoluminal Valve Technology (EVT)

Experimental group

Description:

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

Treatment:

Device: EndoMAXX Endoluminal Valve Technology (EVT)

EndoMAXX

Active Comparator group

Description:

EndoMAXX Fully Covered Esophageal Stent

Treatment:

Device: EndoMAXX