Esophageal Motility DisordersSU-POEMNCT07496840
Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)
An observational study of Esophageal Motility Disorders and Achalasia, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders, Achalasia
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under 18 years of age
- Patients not considered appropriate candidates for POEM by the principal investigator or treating physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Khalaf contact
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Mohamed Othman, MD, 7137980950, mohamed.othman@bcm.edu
Haydee Rochits Cueto, 7137983606, Haydee.RochitsCueto@bcm.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Esophageal Motility Disorders, Achalasia
- Medical subject headings
- Esophageal Motility Disorders, Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Jan 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Othman, MD, Baylor College of Medicine
- Investigators
- Mohamed Othman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496840
- Sponsor's protocol ID
- H-56795
- Acronym
- SU-POEM
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)
- ClinicalTrials.gov ID
- NCT07496840
- Acronym / sponsor ID
- SU-POEM / H-56795
- Conditions
- Esophageal Motility Disorders, Achalasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients not considered appropriate candidates for POEM by the principal investigator or treating physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Technical Success of the Per-Oral Endoscopic Myotomy (POEM) Procedure Using the Speedboat UltraSlim™ Device
Time frame: Day 0
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.
1 secondary outcome
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)
Time frame: Up to 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mai Khalaf contact
Mohamed Othman, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders and Achalasia, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Othman, MD (7137980950, Mohamed.Othman@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.