EndoMAXX EVT Compared to EndoMAXX

Overview

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:

  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.

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20143162

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