Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
| Medical College of Wisconsin | OTHER |
| Indiana University | OTHER |
| University of Colorado, Denver |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoMAXX Endoluminal Valve Technology (EVT) | Experimental | EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve |
|
| EndoMAXX | Active Comparator | EndoMAXX Fully Covered Esophageal Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoMAXX Endoluminal Valve Technology (EVT) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 2 Weeks Following Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kulwinder DUA, MD | Medical College of WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30684601 | Derived | Dua 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EndoMAXX EVT | EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT |
| FG001 | EndoMAXX | EndoMAXX Fully Covered Esophageal Stent EndoMAXX |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EndoMAXX EVT | EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT |
| BG001 | EndoMAXX | EndoMAXX Fully Covered Esophageal Stent EndoMAXX |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
| 1 patient was randomized but not treated and other patients are not included | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks Following Treatment |
|
Adverse Events occurring during the study commencing with the date of treatment through the protocol defined 24 week post-treatment follow-up period, or discontinuation from the study due to study stent removal will be collected.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EndoMAXX Endoluminal Valve Technology (EVT) | EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Dislocation | General disorders | MedDRA (17.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Holland | Merit Medical, Inc | 7816817983 | casey.holland@merit.com |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| OTHER |
| Mayo Clinic | OTHER |
| Weill Medical College of Cornell University | OTHER |
| University of Florida | OTHER |
Not provided
Not provided
Not provided
Not provided
| EndoMAXX | Device |
|
|
| 4 Weeks Following Treament |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
EndoMAXX Fully Covered Esophageal Stent EndoMAXX |
|
|
| 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
| Results at week 4, number of patients analyzed differs from baseline due to inability to continue to follow the patients due to death or lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 4 Weeks Following Treament |
|
|
|
| 12 |
| 29 |
| 19 |
| 29 |
| 15 |
| 29 |
| EG001 | EndoMAXX | EndoMAXX Fully Covered Esophageal Stent | 10 | 30 | 14 | 30 | 11 | 30 |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Device Dislocation | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Non Cardiac Chest Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Sepsis Syndrome | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Shock Haemorrhagic | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Small Intestinal Perforation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Terminal State | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D015154 | Esophageal Motility Disorders |