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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Neoplasm; Endoscopic Submucosal Dissection; Esophageal Polyp; Bipolar Electrocautery
• Intervention / Treatment: Device: Speedboat™ Ultraslim

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Salmaan A Jawaid, MD; Phone Number: 7137980950; Email: Salmaan.Jawaid@bcm.edu
• Study Contact Backup: Name: Haydee Rochits Cueto; Phone Number: 7137983606; Email: Haydee.RochitsCueto@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Principal Investigator: Salmaan Jawaid, MD
      • Sub-Investigator: Mohamed Othman, MD
      • Contact: Salmaan Jawaid, MD; Phone Number: 713-798-0950; Email: Salmaan.Jawaid@bcm.edu
      • Sub-Investigator: Tara Keihanian, MD
      • Contact: Haydee Rochits Cueto; Phone Number: 7137983606; Email: Haydee.RochitsCueto@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment arm; Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD).	Device: Speedboat™ Ultraslim; Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife	Day 1 (procedure day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-electrocautery syndrome	Define as post-procedure abdominal pain, fevers, leukocytosis	24 hours, 2 weeks, and 4 weeks
Rate of esophageal stricturing	Calculated by number of documented occurrences post-procedure for subjects	Assessed at any follow-up post-procedure endoscopies up to 6 months
Degree of scar formation	Scar formation that occurs in response to electrocautery	Assessed at any follow-up post-procedure endoscopies up to 6 months
Speed of Endoscopic Submucosal Dissection	The speed of endoscopic submucosal dissection as calculated by cm^2/hour	During Procedure
Number of instruments used	Logging the variable equipment utilized during the procedure	During 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.	During Procedure
Change in post-procedural pain score	As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain.	24 hours, 2 weeks, and 4 weeks
Cost of dissection	As calculated upon review of devices used during dissection procedure	During Procedure

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Creo Medical Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: H-55206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No