Esophageal NeoplasmNCT06476678
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
An observational study of Esophageal Neoplasm and Esophageal Polyp, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection
- What is being tested?
- Speedboat™ Ultraslim
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 31 Dec 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: All patients undergoing intended ESD of precancerous lesions will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approach individually for further discussion about the study and obtaining informed consent.
Who may be able to join
- Patient is >18 years of age
- Patient can provide informed consent
- Patient is referred for resection of precancerous lesions meeting the following criteria:
- Mucosal based polyp
- Located gastroesophageal junction (GEJ) or proximal to GEJ
- No previous endoscopic resection attempted (EMR or ESD)
Who cannot join
- Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
- Lesions extending past GEJ
- Subepithelial lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Haydee Rochits Cueto, 7137983606, Haydee.RochitsCueto@bcm.edu
Salmaan Jawaid, MD, 713-798-0950, Salmaan.Jawaid@bcm.edu
About this study
Official title: Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.
Read the detailed description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.
Traditionally, knifes utilizing monopolar current were the preferred tools for endoscopic submucosal dissection. These knifes allow accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation resulting from the tissue healing response to electrocautery. Almost all patients with >60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions since it avoids the need for morbid surgery.
Recently, a novel Bipolar RFA knife was FDA approved for endoscopic submucosal dissection. The low voltage bipolar system allows for precise cutting of submucosa and muscle using substantially less energy, thereby limiting inadvertent remote thermal effects. Additionally, it allows aggressive coagulation of vessels without dissipation of large amounts of energy, thereby allowing more targeted therapy. Moreover, with the addition of an integrated injection needle, the knife now allows injection, safe cutting and coagulation in one device, potentially supporting more efficient dissection. Ultimately, due to less thermal effect on surrounding tissue, the bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.
- Conditions
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electrocautery
- Being tested
- Speedboat™ Ultraslim
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speedboat™ UltraslimDevice
Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD). Receives: Device: Speedboat™ Ultraslim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife
Measured: Day 1 (procedure day)
Secondary outcomes (8)
Speed of Endoscopic Submucosal Dissection
The speed of endoscopic submucosal dissection as calculated by cm^2/hour
Measured: During Procedure
Number of instruments used
Logging the variable equipment utilized during the procedure
Measured: During Procedure
Rate of muscle injury score
As calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score.
Measured: During Procedure
Rate of post-electrocautery syndrome
Define as post-procedure abdominal pain, fevers, leukocytosis
Measured: 24 hours, 2 weeks, and 4 weeks
Change in post-procedural pain score
As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain.
Measured: 24 hours, 2 weeks, and 4 weeks
Rate of esophageal stricturing
Calculated by number of documented occurrences post-procedure for subjects
Measured: Assessed at any follow-up post-procedure endoscopies up to 6 months
Degree of scar formation
Scar formation that occurs in response to electrocautery
Measured: Assessed at any follow-up post-procedure endoscopies up to 6 months
Cost of dissection
As calculated upon review of devices used during dissection procedure
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Creo Medical Limited
- Responsible party
- Principal investigator, Fares Ayoub, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476678
- Sponsor's protocol ID
- H-55206
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT06476678
- Acronym / sponsor ID
- H-55206
- Conditions
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electrocautery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Creo Medical Limited
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.
Detailed description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.
Traditionally, knifes utilizing monopolar current were the preferred tools for endoscopic submucosal dissection. These knifes allow accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation resulting from the tissue healing response to electrocautery. Almost all patients with >60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions since it avoids the need for morbid surgery.
Recently, a novel Bipolar RFA knife was FDA approved for endoscopic submucosal dissection. The low voltage bipolar system allows for precise cutting of submucosa and muscle using substantially less energy, thereby limiting inadvertent remote thermal effects. Additionally, it allows aggressive coagulation of vessels without dissipation of large amounts of energy, thereby allowing more targeted therapy. Moreover, with the addition of an integrated injection needle, the knife now allows injection, safe cutting and coagulation in one device, potentially supporting more efficient dissection. Ultimately, due to less thermal effect on surrounding tissue, the bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | – | Device: Speedboat™ UltraslimPatients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing intended ESD of precancerous lesions will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approach individually for further discussion about the study and obtaining informed consent.
Key inclusion criteria (6 listed)
- Patient is >18 years of age
- Patient can provide informed consent
- Patient is referred for resection of precancerous lesions meeting the following criteria:
Key exclusion criteria (3 listed)
- Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
- Lesions extending past GEJ
- Subepithelial lesions
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 |
|---|---|---|
| Speedboat™ UltraslimUse of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions. | Device | Treatment arm |
Primary outcome
Technical success
Time frame: Day 1 (procedure day)
Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife
8 secondary outcomes
Speed of Endoscopic Submucosal Dissection
Time frame: During Procedure
Number of instruments used
Time frame: During Procedure
Rate of muscle injury score
Time frame: During Procedure
Rate of post-electrocautery syndrome
Time frame: 24 hours, 2 weeks, and 4 weeks
Change in post-procedural pain score
Time frame: 24 hours, 2 weeks, and 4 weeks
Rate of esophageal stricturing
Time frame: Assessed at any follow-up post-procedure endoscopies up to 6 months
Degree of scar formation
Time frame: Assessed at any follow-up post-procedure endoscopies up to 6 months
Cost of dissection
Time frame: During 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 4 Nov 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.
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 Neoplasm and Esophageal Polyp, 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 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 Salmaan A Jawaid, MD (7137980950, Salmaan.Jawaid@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Day 1 (procedure day)). 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 4 Nov 2026.