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

NCT07496840 | Recruiting

• 1 other identifier: H-56795
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Motility Disorders; Achalasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  Up to 12 months post-procedure

Other Outcomes (1)

• Incidence of Adverse Events

  Up to 12 months post-procedure

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Motility Disorders; Esophageal Achalasia

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mohamed Othman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Othman, MD

CONTACT

7137980950; Mohamed.Othman@bcm.edu

Mai Khalaf

CONTACT

Mai.Khalaf@bcm.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)