Not a traditional drug phase: Speedboat™ Ultraslim for Esophageal Neoplasm
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.
Official registry: https://clinicaltrials.gov/study/NCT06476678 · Baylor College of Medicine · enrollment listed as 50
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 50 people at Houston. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Interventions: Speedboat™ Ultraslim
Primary outcome (registry wording): Technical success
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Patient is \>18 years of age
- 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 the registry excludes
- Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
- Lesions extending past GEJ
- Subepithelial lesions
Public study contact (from the registry)
Salmaan A Jawaid, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Baylor College of Medicine — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT06476678 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06476678?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06476678?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary