NCT06476678 Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
| NCT ID | NCT06476678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Esophageal Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-10-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06476678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06476678 currently recruiting?
Yes, NCT06476678 is actively recruiting participants. Contact the research team at Salmaan.Jawaid@bcm.edu for enrollment information.
Where is the NCT06476678 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06476678 clinical trial?
NCT06476678 is sponsored by Baylor College of Medicine. The trial plans to enroll 50 participants.