Malignant Esophageal StricturesNCT02159898
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
A study testing EndoMAXX Endoluminal Valve Technology (EVT) and EndoMAXX in people with Malignant Esophageal Strictures, run by Merit Medical Systems, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Esophageal Strictures
- What is being tested?
- EndoMAXX Endoluminal Valve Technology (EVT) and EndoMAXX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or older
- Patient (or legal representative) is able to understand and provide signed informed consent
- Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Who cannot join
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is contraindicated for endoscopic procedure for any reason
- Patient presents with esophagorespiratory fistula
- Patient has previously undergone esophageal stenting or esophagectomy
- Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
- Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
Show all 9Show fewer
- Removal of stent is scheduled to occur within six months
- Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Denver
Aurora, Colorado, 80045
Geisinger Medical Center
Danville, Pennsylvania, 17822
University of Florida
Gainesville, Florida, 32608
Indiana University
Indianapolis, Indiana, 46202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell Medical College
New York, New York, 10021
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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
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
- Malignant Esophageal Strictures
- Being tested
- EndoMAXX Endoluminal Valve Technology (EVT), EndoMAXX
- Keywords
- Esophageal Cancer, Dysphagia, Regurgitation
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoMAXX Endoluminal Valve Technology (EVT)Device
Also called EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
EndoMAXXDevice
Also called EndoMAXX Fully Covered Esophageal Stent
| Study group | Role | What they receive |
|---|---|---|
| EndoMAXX Endoluminal Valve Technology (EVT) | Experimental | EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve Receives: Device: EndoMAXX Endoluminal Valve Technology (EVT) |
| EndoMAXX | Active comparator | EndoMAXX Fully Covered Esophageal Stent Receives: Device: EndoMAXX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 Weeks Following Treatment
Secondary outcomes (1)
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
Measured: 4 Weeks Following Treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Esophageal StricturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic, Medical College of Wisconsin, Indiana University, University of Colorado, Denver, Mayo Clinic, Weill Medical College of Cornell University, University of Florida
- Responsible party
- Sponsor
- Investigators
- Kulwinder DUA, MD, Principal investigator, Medical College of WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159898
- Sponsor's protocol ID
- ESO-P3-12-02
- Status last verified
- May 2018
- First submitted
- 6 Jun 2014
- Last updated
- 7 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 30684601
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02159898
- Acronym / sponsor ID
- ESO-P3-12-02
- Conditions
- Malignant Esophageal Strictures
- Keywords
- Esophageal Cancer, Dysphagia, Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic, Medical College of Wisconsin, Indiana University, University of Colorado, Denver, Mayo Clinic, Weill Medical College of Cornell University, University of Florida
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoMAXX Endoluminal Valve Technology (EVT) | Experimental | Device: EndoMAXX Endoluminal Valve Technology (EVT)EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve |
| EndoMAXX | Active comparator | Device: EndoMAXXEndoMAXX Fully Covered Esophageal Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older
- Patient (or legal representative) is able to understand and provide signed informed consent
- Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
Key exclusion criteria (9 listed)
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is contraindicated for endoscopic procedure for any reason
- Patient presents with esophagorespiratory fistula
- Patient has previously undergone esophageal stenting or esophagectomy
- Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoMAXX Endoluminal Valve Technology (EVT)Also: EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve | Device | EndoMAXX Endoluminal Valve Technology (EVT) |
| EndoMAXXAlso: EndoMAXX Fully Covered Esophageal Stent | Device | EndoMAXX |
Primary outcome
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
Time frame: 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
1 secondary outcome
GERD-HRQL
Time frame: 4 Weeks Following Treament
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30684601Dua 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.
Related trials for Malignant Esophageal Strictures
Recruiting
Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Oesophageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kulwinder DUA, MD principal investigator
Medical College of WI
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoMAXX Endoluminal Valve Technology (EVT) and EndoMAXX in people with Malignant Esophageal Strictures, run by Merit Medical Systems, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment (time frame: 2 Weeks Following Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.