Clinical trial · Interventional
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Esophageal Strictures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoMAXX | Device | — | UNRESOLVED |
| EndoMAXX Endoluminal Valve Technology (EVT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EndoMAXX Endoluminal Valve Technology (EVT)
- description
- EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
- interventionNames
- Device: EndoMAXX Endoluminal Valve Technology (EVT)
- type
- ACTIVE_COMPARATOR
- label
- EndoMAXX
- description
- EndoMAXX Fully Covered Esophageal Stent
- interventionNames
- Device: EndoMAXX
Primary outcomes (1)
- measure
- Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
- timeFrame
- 2 Weeks Following Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDua KS, DeWitt JM, Kessler WR, Diehl DL, Draganov PV, Wagh MS, Kahaleh M, Wong Kee Song LM, Khara HS, Khan AH, Aburajab MM, Ballard D, Forsmark CE, Edmundowicz SA, Brauer BC, Tyberg A, Buttar NS, Adler DG. A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). Gastrointest Endosc. 2019 Jul;90(1):64-74.e3. doi: 10.1016/j.gie.2019.01.013. Epub 2019 Jan 23. PMID 30684601