Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476678
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Brief Title:
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Both Baylor St Lukes 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None