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Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06476678
Enrollment
50
Registered
2024-06-26
Start date
2024-10-15
Completion date
2027-12-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Electrocautery, Endoscopic Submucosal Dissection, Esophageal Neoplasm, Esophageal Polyp

Brief 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. 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.

Interventions

DEVICESpeedboat™ Ultraslim

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Sponsors

Baylor College of Medicine
Lead SponsorOTHER
Creo Medical Limited
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000 * Lesions extending past GEJ * Subepithelial lesions

Design outcomes

Primary

MeasureTime frameDescription
Technical successDay 1 (procedure day)Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife

Secondary

MeasureTime frameDescription
Speed of Endoscopic Submucosal DissectionDuring ProcedureThe speed of endoscopic submucosal dissection as calculated by cm\^2/hour
Number of instruments usedDuring ProcedureLogging the variable equipment utilized during the procedure
Rate of muscle injury scoreDuring ProcedureAs calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score.
Rate of post-electrocautery syndrome24 hours, 2 weeks, and 4 weeksDefine as post-procedure abdominal pain, fevers, leukocytosis
Change in post-procedural pain score24 hours, 2 weeks, and 4 weeksAs calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain.
Rate of esophageal stricturingAssessed at any follow-up post-procedure endoscopies up to 6 monthsCalculated by number of documented occurrences post-procedure for subjects
Degree of scar formationAssessed at any follow-up post-procedure endoscopies up to 6 monthsScar formation that occurs in response to electrocautery
Cost of dissectionDuring ProcedureAs calculated upon review of devices used during dissection procedure

Countries

United States

Contacts

CONTACTSalmaan A Jawaid, MD
Salmaan.Jawaid@bcm.edu7137980950
CONTACTHaydee Rochits Cueto
Haydee.RochitsCueto@bcm.edu7137983606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026