Esophageal Motility DisordersNCT05272046
Monopolar and Bipolar Current RFA Knife in POEM
A study testing Per-oral Endoscopic Myotomy and Speedboat (Bipolar electrocautery knife) in people with Esophageal Motility Disorders, run by Baylor College of Medicine at 3 sites in 3 countries.
Trial summary
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- Per-oral Endoscopic Myotomy and Speedboat (Bipolar electrocautery knife)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Feb 2022to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age greater than or equal to 18 years of age
- Able to sign consent - Planned POEM procedure for all indications
Who cannot join
- Pregnant patients
- Prisoners
- Unable to sign consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
India1 site
Asian Institute of Gastroenterology (AIG) Hospitals
Hyderabad, 500082
About this study
Official title: Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.
Read the detailed description
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. The procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. More importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. The Speedboat-RSD has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (BRF) and microwave energy to dissect tissue/coagulate vessels. In essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). It is FDA approved for submucosal dissection (ESD) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in POEM (3). Currently, the investigators have been performing EGD with the POEM procedure using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post-procedural related pain.
- Conditions
- Esophageal Motility Disorders
- Being tested
- Per-oral Endoscopic Myotomy, Speedboat (Bipolar electrocautery knife)
- Keywords
- Achalasia, Dysphagia, Per-Oral Endoscopic Myotomy, Bipolar electrocautery
- Medical subject headings
- Esophageal Motility Disorders, Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per-oral Endoscopic MyotomyProcedure or surgery
Also called POEM
Therapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders.
Speedboat (Bipolar electrocautery knife)Device
Also called Speedboat Inject
Use of Creo Medical's Speedboat RS2 knife and generator in performing the POEM procedure for patients presenting with an esophageal motility disorder.
| Study group | Role | What they receive |
|---|---|---|
| Monopolar Electrocautery tool | Active comparator | Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure. Receives: Procedure: Per-oral Endoscopic Myotomy |
| Bipolar Electrocautery tool | Experimental | Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure. Receives: Procedure: Per-oral Endoscopic Myotomy; Device: Speedboat (Bipolar electrocautery knife) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
Use of a Visual Analog Scale (VAS) from 0-10 with "0" being no pain and "10" being the worse pain to assess overall pain following the POEM procedure up to 24 hours.
Measured: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.
Secondary outcomes (5)
Technical success rate of patients who completed POEM procedure with the bipolar knife.
Completion of POEM procedure with the Speedboat-RS2 knife
Measured: Day 1
Total procedure time (minutes)
Includes time from incision, tunneling, dissection and closure.
Measured: Day 1
Study knife removal during procedure
Total number of times the Speedboat knife needed to be removed for another device during mucosal incision, submucosal dissection, or myotomy.
Measured: Day 1
Hospital Length-of-stay
Number of days patient remains in hospital following procedure
Measured: Up to 1 week
Adverse events
Collection of unanticipated medical occurrences within a 12 month time frame.
Measured: 1 month, 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start22 Feb 2022
- Primary completion19 Feb 2024
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salmaan Azam Jawaid, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272046
- Sponsor's protocol ID
- H-50587
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Jung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29.
PubMed 23990482Saunders B P, Tsiamoulos Z P, Bourikas L et al.The
Patil G, Dalal A, Maydeo AP. Feasibility of Speedboat RS2 with bipolar radiofrequency energy for peroral endoscopic myotomy in patients with achalasia (with video). Endosc Int Open. 2020 Aug;8(8):E998-E1001. doi: 10.1055/a-1165-0087. Epub 2020 Jul 21.
PubMed 32743048
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)
- ClinicalTrials.gov ID
- NCT05272046
- Acronym / sponsor ID
- H-50587
- Conditions
- Esophageal Motility Disorders
- Keywords
- Achalasia, Dysphagia, Per-Oral Endoscopic Myotomy, Bipolar electrocautery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 9 Mar 2022 (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.
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.
Detailed description
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. The procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. More importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. The Speedboat-RSD has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (BRF) and microwave energy to dissect tissue/coagulate vessels. In essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). It is FDA approved for submucosal dissection (ESD) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in POEM (3). Currently, the investigators have been performing EGD with the POEM procedure using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post-procedural related pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.
| Arm | Type | Receives |
|---|---|---|
| Monopolar Electrocautery tool | Active comparator | Procedure: Per-oral Endoscopic MyotomyPatients randomized into this group will receive the standard of care monopolar tool for their POEM procedure. |
| Bipolar Electrocautery tool | Experimental | Procedure: Per-oral Endoscopic Myotomy, Device: Speedboat (Bipolar electrocautery knife)Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years of age
- Able to sign consent - Planned POEM procedure for all indications
Key exclusion criteria (3 listed)
- Pregnant patients
- Prisoners
- Unable to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per-oral Endoscopic MyotomyAlso: POEMTherapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders. | Procedure or surgery | Bipolar Electrocautery tool, Monopolar Electrocautery tool |
| Speedboat (Bipolar electrocautery knife)Also: Speedboat InjectUse of Creo Medical's Speedboat RS2 knife and generator in performing the POEM procedure for patients presenting with an esophageal motility disorder. | Device | Bipolar Electrocautery tool |
Primary outcome
Change in pain score
Time frame: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.
Use of a Visual Analog Scale (VAS) from 0-10 with "0" being no pain and "10" being the worse pain to assess overall pain following the POEM procedure up to 24 hours.
5 secondary outcomes
Technical success rate of patients who completed POEM procedure with the bipolar knife.
Time frame: Day 1
Total procedure time (minutes)
Time frame: Day 1
Study knife removal during procedure
Time frame: Day 1
Hospital Length-of-stay
Time frame: Up to 1 week
Adverse events
Time frame: 1 month, 3 months, 6 months, and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 23990482Jung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29.
- BackgroundSaunders B P, Tsiamoulos Z P, Bourikas L et al.The
- Background: PubMed 32743048Patil G, Dalal A, Maydeo AP. Feasibility of Speedboat RS2 with bipolar radiofrequency energy for peroral endoscopic myotomy in patients with achalasia (with video). Endosc Int Open. 2020 Aug;8(8):E998-E1001. doi: 10.1055/a-1165-0087. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Esophageal Motility Disorders
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per-oral Endoscopic Myotomy and Speedboat (Bipolar electrocautery knife) in people with Esophageal Motility Disorders, run by Baylor College of Medicine at 3 sites in 3 countries.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 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 3 sites in United States, India, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272046, which also lists 3 linked publications.
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 8 Jun 2026.