Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monopolar Current Cutting Knife vs Bipolar RFA Knife

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919824
Recruitment Status : Not yet recruiting
First Posted : June 9, 2021
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Othman, Baylor College of Medicine

Brief Summary:
This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of Creo Medical's novel Bipolar RS2 Speedboat Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ESD) procedure at Baylor St. Luke's Medical Center.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Procedure: Endoscopic Submucosal Dissection Procedure: Endoscopic Mucosal Resection Not Applicable

Detailed Description:

Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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 such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows 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 abdominal pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. Recently, a novel bipolar Radiofrequency Ablation (RFA) knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome.

Our tertiary referral center Baylor St Luke's Medical Center is center of excellence for ESD procedure and we have previously reported our ESD experience using specialized stability and traction device and monopolar current knife in 111 patients. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in colonic endoscopic submucosal dissection.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in Colonic Endoscopic Submucosal Dissection
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Bipolar Knife
ESD procedure performed with Creo Medical Speedboat RS2.
Procedure: Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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.
Other Name: ESD

Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.
Other Name: EMR, Endoscopic resection

Active Comparator: Monopolar Knife
ESD procedure performed with monopolar knives.
Procedure: Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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.
Other Name: ESD

Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.
Other Name: EMR, Endoscopic resection




Primary Outcome Measures :
  1. Procedure time [ Time Frame: Day 1 ]
    The speed of endoscopic submucosal dissection as calculated by cm2/hour


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: Day 1, 4 weeks ]
    En-bloc, R0 and curative resection rates for each knife

  2. Procedural adverse event [ Time Frame: Day 1 ]
    Adverse events during the procedure: hemorrhage, perforation, etc.

  3. Immediate post-procedural adverse event [ Time Frame: Up to 24 hours ]
    Abdominal pain after the procedure using Visual Analogue Scale from 1 to 10

  4. Delayed post-procedural adverse event [ Time Frame: 4 weeks ]
    Post polypectomy syndrome in both groups up to one month after the procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is ≥ 18 years old
  2. Patient is capable of providing informed consent
  3. Patient is referred for ESD procedure of gastrointestinal neoplastic lesions

Exclusion Criteria:

  1. Patient is < 18 years old
  2. Patient refused and/or unable to provide consent
  3. Patient is a pregnant woman
  4. Patients with lesions removed with other techniques besides ESD or a modified ESD technique (i.e., EMR or TEM) as defined in the Japan Gastroenterological Endoscopy Society (JGES) guidelines for endoscopic resection of lesions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919824


Contacts
Layout table for location contacts
Contact: Michael Mercado 7137983606 Michael.Mercado@bcm.edu
Contact: Sylvia Pena Munoz, MD 7137982308 Sylvia.PenaMunoz@bcm.edu

Locations
Layout table for location information
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Publications:

Layout table for additonal information
Responsible Party: Mohamed Othman, M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04919824    
Other Study ID Numbers: H-49483
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a randomized prospective single-center study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Othman, Baylor College of Medicine:
Endoscopic Submucosal Dissection
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases