N/A
N=60
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
Malignant Esophageal Strictures
Bottom Line
View on ClinicalTrials.gov: NCT02159898 ↗Enrolled (actual)
60
Serious AEs
55.9%
Results posted
Jun 2018
Primary outcome: Primary: Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment — 0.6; 0.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EndoMAXX Endoluminal Valve Technology (EVT) (Device); EndoMAXX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merit Medical Systems, Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment |
0.6; 0.6 | — |
| SECONDARY GERD-HRQL |
6.4; 6.3 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02159898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.