A Study Of Novel Thin Therapeutic Endoscope In Peroral Endoscopic Myotomy
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 25-012989
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.
More information
Publications
Publications are currently not available