About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is >18 years of age
Patient can provide informed consent
Mucosal based polyp
Located gastroesophageal junction (GEJ) or proximal to GEJ
Disqualifiers
Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
Lesions extending past GEJ
Subepithelial lesions
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Speedboat™ Ultraslim
DeviceUse of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.
Treatment groups
Trial outcomes
Primary outcomes
Technical success
Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife
Secondary outcomes
Speed of Endoscopic Submucosal Dissection
The speed of endoscopic submucosal dissection as calculated by cm\^2/hour
Number of instruments used
Logging the variable equipment utilized during the 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.
Rate of post-electrocautery syndrome
Define as post-procedure abdominal pain, fevers, leukocytosis
Sponsors and contacts
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Baylor College of Medicine
Lead sponsor
Creo Medical Limited
Collaborator