Malignant Esophageal Strictures Clinical Trial
Official title:
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
| NCT number | NCT02159898 |
| Other study ID # | ESO-P3-12-02 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | December 2016 |
| Verified date | May 2018 |
| Source | Merit Medical Systems, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado Denver | Aurora | Colorado |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | University of Florida | Gainesville | Florida |
| United States | Indiana University | Indianapolis | Indiana |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Merit Medical Systems, Inc. | Geisinger Clinic, Indiana University, Mayo Clinic, Medical College of Wisconsin, University of Colorado, Denver, University of Florida, Weill Medical College of Cornell University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment | The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment. Scale: 0 = able to eat normal diet / no dysphagia. = able to swallow some solid foods = able to swallow only semi solid foods = able to swallow liquids only = unable to swallow anything / total dysphagia |
2 Weeks Following Treatment | |
| Secondary | GERD-HRQL | Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment. Scale: 0 = No symptom = Symptoms noticeable but not bothersome = Symptoms noticeable and bothersome but not every day = Symptoms bothersome every day = Symptoms affect daily activity = Symptoms are incapacitating to do daily activities |
4 Weeks Following Treament |