A Study Of Novel Thin Therapeutic Endoscope In Peroral Endoscopic Myotomy

Overview

About this study

The purpose of this study is to evaluate the usability and ergonomic performance of the endoscope during POEM using validated workload assessment tools and operator feedback.

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:

  • Adults ≥18 years of age undergoing clinically indicated POEM for esophageal motility disorders (e.g., achalasia, spastic esophageal disorders)

  • Participants able to provide consent

 

Exclusion Criteria: 

  • Age <18 years

  • Pregnancy

  • Patients with uncorrected coagulopathy or who are unable to safely discontinue anticoagulation/antiplatelet therapy for the procedure.

  • Patients with active systemic infection or hemodynamic instability that would increase procedural risk.

  • Patients with significant esophageal pathology (e.g., large varices, malignancy) precluding safe performance of POEM.

  • Patients enrolled in other interventional research studies that may interfere with study endpoints.

  • Patients in whom the use of the investigational therapeutic endoscope is deemed technically unfeasible by the performing endoscopist

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/7/2025. Questions regarding updates should be directed to the study team contact.

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.

Open for enrollment

More information

Publications

Publications are currently not available
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CLS-20598372

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