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CLINICAL OUTCOME, SAFETY, AND EFFECTIVENESS ASSESSMENT OF SPEEDBOAT UTRASLIM™ SURGICAL DEVICE IN THE PERFORMANCE OF PER-ORAL ENDOSCOPIC MYOTOMY (POEM)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study is a prospective registry designed to evaluate the clinical outcomes, safety, and effectiveness of per-oral endoscopic myotomy (POEM) performed using the Speedboat UltraSlim™ device in patients with achalasia or other esophageal motility disorders. Participants included in this registry are those undergoing clinically indicated POEM as part of standard of care. No experimental interventions will be performed as part of this study. Patients will be approached for participation after the clinical decision to perform POEM has already been made. Data will be collected through review of electronic medical records and procedural documentation, including patient demographics, procedural details, and clinical outcomes. Follow-up data will be collected at predefined time points (e.g., 30 days, 3 months, 6 months, and up to 1 year) to assess symptom improvement, procedural success, and adverse events. The primary objective of the study is to assess technical success, clinical success, and safety outcomes associated with the use of the Speedboat UltraSlim™ device during POEM procedures. This registry poses minimal risk to participants, as all procedures are performed as part of routine clinical care. No additional interventions beyond standard care are required for participation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (≥18 years of age)

• Diagnosed with achalasia or other esophageal motility disorders

• Scheduled to undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device

• Able and willing to provide informed consent

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Mohamed Othman, MD
Mohamed.Othman@bcm.edu
7137980950
Backup
Haydee Rochits Cueto
haydee.rochitscueto@bcm.edu
7137983606
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 40
Treatments
Patients Undergoing POEM Using Speedboat UltraSlim™
Patients with achalasia or other esophageal motility disorders undergoing clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device as part of standard clinical care. No experimental interventions are performed.
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov