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Monopolar and Bipolar in Esophageal ESD

NCT05736705 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-27

No results posted yet for this study

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

Interventions

PROCEDURE

Endoscopic Submucosal Dissection

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

DEVICE

Bipolar electrocautery knife

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

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2024-06-25
Completion
2024-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736705 on ClinicalTrials.gov