Actively Recruiting
Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Led by Baylor College of Medicine · Updated on 2026-03-25
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Creo Medical Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new device called the Bipolar Radiofrequency Ablation (RFA) knife for removing esophageal lesions or polyps using a technique called endoscopic submucosal dissection (ESD). This study aims to evaluate the effectiveness, safety, and feasibility of this novel bipolar device compared to traditional monopolar knives, which can cause complications such as post coagulation syndrome and esophageal strictures. The trial is sponsored by Baylor College of Medicine and involves centers experienced in ESD. The procedure involves marking the lesion, injecting a lifting agent beneath it, making circumferential cuts, and dissecting the lesion using the novel Bipolar RFA knife. This device uses a low voltage bipolar current that allows precise cutting and coagulation with less thermal damage to surrounding tissues. It also includes an integrated injection needle to support efficient dissection. Patients eligible for the study will undergo lesion removal using this device during their endoscopy. Participants will be monitored for technical success on the procedure day and followed up to assess procedure speed, instrument use, muscle injury, post-electrocautery syndrome, pain levels, esophageal strictures, scar formation, and cost of dissection. Assessments will be made during and after the procedure, with follow-ups extending up to six months. The study duration for each participant depends on their individual follow-up schedule and outcomes.
CONDITIONS
Brief Title
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is older than 18 years of age
- Patient can provide informed consent
- Patient is referred for resection of precancerous esophageal lesions that are mucosal based polyps
- Lesions are located at the gastroesophageal junction or proximal to it
- No previous endoscopic resection (EMR or ESD) has been attempted on the lesion
You will not qualify if you...
- Patients with International Normalized Ratio (INR) greater than 1.5 or platelet count less than 50,000
- Lesions that extend past the gastroesophageal junction
- Subepithelial lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo endoscopic submucosal dissection using the novel bipolar radiofrequency ablation knife to remove esophageal precancerous lesions.
1 procedure visit (in-person)
Duration - Up to 6 months
Participants are monitored after the procedure for pain, post-electrocautery syndrome, esophageal stricturing, and scar formation.
Follow-up visits at 24 hours, 2 weeks, 4 weeks, and additional visits up to 6 months as needed
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Salmaan A Jawaid, MD
H
Haydee Rochits Cueto
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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