Monopolar and Bipolar in Esophageal ESD

NCT05736705 | Withdrawn FDA Device

• 1 other identifier: H-52921
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Speed of Endoscopic Submucosal Dissection

  The speed of endoscopic submucosal dissection as calculated by cm2/hour

  Day 1 (procedure day)

Secondary Outcomes (5)

• En-bloc resection achieved

  Day 1 (procedure day)

• R0 Resection achieved

  1-3 days post-procedure

• Curative Resection achieved

  1-3 days post-procedure

• Adverse events

  1 month, 3 months, 6 months, 12 months

• Rate of esophageal stricturing post-procedure

  1-3 days post-procedure

Study Arms (2)

Monopolar Electrocautery tool

ACTIVE COMPARATOR

Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure.

Procedure: Endoscopic Submucosal Dissection

Bipolar Electrocautery tool

EXPERIMENTAL

Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.

Procedure: Endoscopic Submucosal Dissection; Device: Bipolar electrocautery knife

Interventions

Endoscopic Submucosal Dissection PROCEDURE

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.

Also known as: ESD, Mucosal Resection

Bipolar Electrocautery tool; Monopolar Electrocautery tool

Bipolar electrocautery knife DEVICE

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.

Also known as: ESD, Mucosal Resection

Bipolar Electrocautery tool

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years old
• Patient is capable of providing informed consent
• Patient is referred for ESD procedure of an esophageal neoplastic lesion

You may not qualify if:

• Patient is \< 18 years old
• Patient refused and/or unable to provide consent
• Patient is a pregnant woman
• Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not know which electrocautery tool will be used in their procedure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 21, 2023
• Study Start: January 23, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)