Achalasia Patient Reported Outcomes

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • Site IRB
    • Rochester, Minnesota: 15-006921
    NCT ID: NCT02606578
    Sponsor Protocol Number: 15-006921

About this study

Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • >18 years old
  • Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
  • Esophagus diameter less <8 cm on barium swallow test

Exclusion Criteria:

  • Pregnant
  • Diverticular disease of the esophagus
  • Barrett's esophagus
  • Extensive abdominal adhesions
  • <50% predicted FEV1 on pulmonary function testing
  • Cardiac ejection fraction <25%
  • Esophageal stricture from prior myotomy
  • Sigmoidization of the esophagus
  • More than one prior balloon dilation (>3 cm) or any prior dilation of 3 cm

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

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CLS-20168942

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