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

Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Motility Disorders; Achalasia

Detailed Description

Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and absence of normal esophageal peristalsis, resulting in dysphagia and other symptoms. Per-oral endoscopic myotomy (POEM) has emerged as a minimally invasive and effective treatment option for achalasia and other esophageal motility disorders.

The Speedboat UltraSlim™ surgical device is a novel endoscopic instrument that enables simultaneous dissection and coagulation, potentially improving procedural efficiency and safety. This study aims to evaluate the technical feasibility, clinical outcomes, and safety profile of POEM procedures performed using this device.

This study is designed as a prospective, single-center registry including patients undergoing clinically indicated POEM procedures as part of standard of care. No experimental interventions will be introduced, and all procedures will be performed according to routine clinical practice by experienced endoscopists. Patients will be approached for participation after the clinical decision to perform POEM has been established.

Eligible participants include adult patients diagnosed with achalasia or other esophageal motility disorders who are scheduled to undergo POEM. Patients who are not considered appropriate candidates for the procedure or who are under 18 years of age will be excluded.

Data will be collected through electronic medical record review and procedural documentation. Variables collected will include patient demographics, clinical characteristics, procedural details (e.g., procedure duration, technical success), and peri-procedural outcomes. Safety outcomes will include intra-procedural and post-procedural adverse events.

Follow-up data will be collected at predefined intervals, including approximately 30 days, 3 months, 6 months, and up to 1 year after the procedure. Clinical outcomes will include symptom improvement assessed using validated measures such as the Eckardt score, as well as objective findings from endoscopy and manometry when available.

The primary objectives of this registry are to assess technical success, clinical success, and safety outcomes associated with POEM using the Speedboat UltraSlim™ device. Secondary analyses may include evaluation of procedural efficiency, adverse event rates, and need for additional interventions.

As this is an observational registry study, participation does not alter clinical management. The study presents minimal risk to participants, primarily related to data confidentiality. All data will be coded and stored in secure, password-protected systems in compliance with institutional policies and applicable regulations. No protected health information will be shared outside the study site.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Mohamed Othman, MD; Phone Number: 7137980950; Email: mohamed.othman@bcm.edu
• Study Contact Backup: Name: Haydee Rochits Cueto; Phone Number: 7137983606; Email: Haydee.RochitsCueto@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Sub-Investigator: Tara Keihanian, MD
      • Contact: Mohamed Othman, MD; Phone Number: 7137980950; Email: mohamed.othman@bcm.edu
      • Contact: Haydee Rochits Cueto; Phone Number: 7137983606; Email: Haydee.RochitsCueto@bcm.edu
      • Sub-Investigator: Salmaan Jawaid, MD
      • Sub-Investigator: Fares Ayoub, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with achalasia or other esophageal motility disorders who are undergoing clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device as part of standard clinical care. Patients are identified through routine clinical practice and enrolled prospectively after providing informed consent.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients under 18 years of age
• Patients not considered appropriate candidates for POEM by the principal investigator or treating physician

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Technical Success of the Per-Oral Endoscopic Myotomy (POEM) Procedure Using the Speedboat UltraSlim™ Device	Technical success is defined as successful completion of the per-oral endoscopic myotomy (POEM) procedure using the Speedboat UltraSlim™ device as intended, without the need for conversion to an alternative device or procedure.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Clinical Success Based on Improvement in Eckardt Score (Range: 0-12, Higher Scores Indicate Worse Symptoms) After Per-Oral Endoscopic Myotomy (POEM)	Clinical success is defined as improvement in symptoms following per-oral endoscopic myotomy (POEM), assessed using the Eckardt Symptom Score (range: 0-12, with higher scores indicating more severe symptoms). Clinical success is defined as a post-procedure Eckardt score ≤3.	Up to 12 months post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Number and type of intra-procedural and post-procedural adverse events associated with POEM using the Speedboat UltraSlim™ device.	Up to 12 months post-procedure

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Mohamed Othman, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Deglutition Disorders; Esophageal Achalasia; Esophageal Motility Disorders
• Other Study ID Numbers: H-56795

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No