Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT07496840
Status
Recruiting
Apply to this trial

Conditions

  • Achalasia
  • Esophageal Motility Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of Participants with Technical Success of the Per-Oral Endoscopic Myotomy (POEM) Procedure Using the Speedboat UltraSlim™ Device [ Time Frame: Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Mohamed Othman, MD
[email protected]
7137980950
Haydee Rochits Cueto
[email protected]
7137983606
Salmaan Jawaid, MD (SUB_INVESTIGATOR)
Tara Keihanian, MD (SUB_INVESTIGATOR)
Fares Ayoub, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
Baylor College of Medicine· Houston, TX

Related Studies