Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

NCT ID: NCT06476678

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Esophageal Neoplasm; Esophageal Polyp; Endoscopic Submucosal Dissection; Bipolar Electrocautery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Speedboat™ Ultraslim

Intervention Type: DEVICE

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Interventions

Speedboat™ Ultraslim

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creo Medical Limited

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Salmaan Azam Jawaid, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Salmaan A Jawaid, MD

Role: CONTACT

Phone: 7137980950

Email: Salmaan.Jawaid@bcm.edu

Michael Mercado, B.S

Role: CONTACT

Phone: 7137983606

Email: Michael.Mercado@bcm.edu

Facility Contacts

Michael Mercado

Role: primary

Salmaan Jawaid, MD

Role: backup

Other Identifiers

H-55206

Identifier Type: -

Identifier Source: org_study_id