Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients under 18 years of age
Patients not considered appropriate candidates for POEM by the principal investigator or treating physician
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Patients Undergoing POEM Using Speedboat UltraSlim™
Trial outcomes
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.
Time frame
Day 0Secondary 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)
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.
Time frame
Up to 12 months post-procedureOther outcomes
1
Incidence of Adverse Events
Number and type of intra-procedural and post-procedural adverse events associated with POEM using the Speedboat UltraSlim™ device.
Time frame
Up to 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov