Trial Outcomes & Findings for EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX (NCT NCT02159898)

Last Updated: 2018-06-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

2 Weeks Following Treatment

Results posted on

2018-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	EndoMAXX EVT EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT	EndoMAXX EndoMAXX Fully Covered Esophageal Stent EndoMAXX
Overall Study STARTED	30	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EndoMAXX EVT n=30 Participants EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT	EndoMAXX n=30 Participants EndoMAXX Fully Covered Esophageal Stent EndoMAXX	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Weeks Following Treatment

Population: 1 patient was randomized but not treated and other patients are not included

Outcome measures

Outcome measures
Measure	EndoMAXX EVT n=25 Participants EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT	EndoMAXX n=27 Participants EndoMAXX Fully Covered Esophageal Stent EndoMAXX
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment	0.6 units on a scale Standard Deviation 0.7	0.6 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	EndoMAXX EVT n=17 Participants EndoMAXX EVT Fully Covered Esophageal Stent with Valve EndoMAXX EVT	EndoMAXX n=25 Participants EndoMAXX Fully Covered Esophageal Stent EndoMAXX
GERD-HRQL	6.4 units on a scale Standard Deviation 5.7	6.3 units on a scale Standard Deviation 6.9

Adverse Events

EndoMAXX Endoluminal Valve Technology (EVT)

Serious events: 19 serious events

Other events: 15 other events

Deaths: 12 deaths

EndoMAXX

Serious events: 14 serious events

Other events: 11 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	EndoMAXX Endoluminal Valve Technology (EVT) n=29 participants at risk EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve	EndoMAXX n=30 participants at risk EndoMAXX Fully Covered Esophageal Stent
General disorders Device Dislocation	48.3% 14/29 • Number of events 14 • 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.	33.3% 10/30 • Number of events 10 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	3.4% 1/29 • Number of events 2 • 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.	3.3% 1/30 • Number of events 1 • 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.

Additional Information

Casey Holland

Merit Medical, Inc

Phone: 7816817983

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	EndoMAXX Endoluminal Valve Technology (EVT) n=29 participants at risk EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve	EndoMAXX n=30 participants at risk EndoMAXX Fully Covered Esophageal Stent
Gastrointestinal disorders Abdominal Pain	6.9% 2/29 • Number of events 2 • 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.	0.00% 0/30 • 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.
General disorders Asthenia	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Infections and infestations Bacteraemia	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Cardiac disorders Bradycardia	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Cardiac disorders Cardiac Arrest	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Nervous system disorders Cerebrovascular Accident	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
General disorders Chest Pain	6.9% 2/29 • Number of events 2 • 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.	0.00% 0/30 • 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.
Psychiatric disorders Confusional State	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Metabolism and nutrition disorders Dehydration	13.8% 4/29 • Number of events 5 • 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.	3.3% 1/30 • Number of events 1 • 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.
General disorders Device Dislocation	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Gastrointestinal disorders Dysphagia	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Infections and infestations Empyema	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Blood and lymphatic system disorders Febrile Neutropenia	3.4% 1/29 • Number of events 2 • 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.	0.00% 0/30 • 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.
Injury, poisoning and procedural complications Gastrointestinal Stoma Complication	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Gastrointestinal disorders Haematemesis	3.4% 1/29 • Number of events 1 • 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.	3.3% 1/30 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypokalaemia	3.4% 1/29 • Number of events 1 • 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.	3.3% 1/30 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Psychiatric disorders Mental Status Changes	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 2 • 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.
General disorders Non Cardiac Chest Pain	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Gastrointestinal disorders Oesophageal Stenosis	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Gastrointestinal disorders Oesophagitis	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Infections and infestations Pneumonia	3.4% 1/29 • Number of events 1 • 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.	3.3% 1/30 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	3.4% 1/29 • Number of events 1 • 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.	3.3% 1/30 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Renal and urinary disorders Renal Failure Acute	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Infections and infestations Sepsis	13.8% 4/29 • Number of events 4 • 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.	3.3% 1/30 • Number of events 1 • 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.
Infections and infestations Sepsis Syndrome	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Vascular disorders Shock Haemorrhagic	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Gastrointestinal disorders Small Intestinal Perforation	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
General disorders Terminal State	3.4% 1/29 • Number of events 1 • 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.	0.00% 0/30 • 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.
Infections and infestations Urosepsis	0.00% 0/29 • 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.	3.3% 1/30 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • 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.	3.3% 1/30 • Number of events 2 • 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.