Malignant Esophageal Strictures
Conditions
Keywords
Esophageal Cancer, Dysphagia, Regurgitation
Brief 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).
Interventions
DEVICEEndoMAXX Endoluminal Valve Technology (EVT)
DEVICEEndoMAXX
Sponsors
Geisinger Clinic
Medical College of Wisconsin
Indiana University
University of Colorado, Denver
Mayo Clinic
Weill Medical College of Cornell University
University of Florida
Merit Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment | 2 Weeks Following 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. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GERD-HRQL | 4 Weeks Following Treament | 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 1. = Symptoms noticeable but not bothersome 2. = Symptoms noticeable and bothersome but not every day 3. = Symptoms bothersome every day 4. = Symptoms affect daily activity 5. = Symptoms are incapacitating to do daily activities |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoMAXX EVT EndoMAXX EVT Fully Covered Esophageal Stent with Valve
EndoMAXX EVT | 30 |
| EndoMAXX EndoMAXX Fully Covered Esophageal Stent
EndoMAXX | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | EndoMAXX EVT | EndoMAXX |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 14 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 16 Participants | 13 Participants |
| Region of Enrollment United States | 59 Participants | 29 Participants | 30 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 52 Participants | 25 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 29 | 10 / 30 |
| other Total, other adverse events | 15 / 29 | 11 / 30 |
| serious Total, serious adverse events | 19 / 29 | 14 / 30 |
Outcome results
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. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
Time frame: 2 Weeks Following Treatment
Population: 1 patient was randomized but not treated and other patients are not included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoMAXX EVT | Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment | 0.6 units on a scale | Standard Deviation 0.7 |
| EndoMAXX | Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment | 0.6 units on a scale | Standard Deviation 0.9 |
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 1. = Symptoms noticeable but not bothersome 2. = Symptoms noticeable and bothersome but not every day 3. = Symptoms bothersome every day 4. = Symptoms affect daily activity 5. = Symptoms are incapacitating to do daily activities
Time frame: 4 Weeks Following Treament
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoMAXX EVT | GERD-HRQL | 6.4 units on a scale | Standard Deviation 5.7 |
| EndoMAXX | GERD-HRQL | 6.3 units on a scale | Standard Deviation 6.9 |