EndoMAXX EVT Compared to EndoMAXX
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003169
NCT ID: NCT02159898
Sponsor Protocol Number: ES0P31202
About this study
This is a prospective, single blinded, randomized study of EndoMAXX 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 EVT Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Louis Wong Kee Song, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available