MedTrace Logo

Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD

NCT03846609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2020-12-11

No results posted yet for this study

Summary

The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.

Conditions

  • Colonic Polyp

Interventions

DEVICE

double balloon interventional platform (DiLumen)

double balloon interventional platform (DiLumen) is used for removal of colonic polyp

DEVICE

no double balloon interventional platform (DiLumen)

double balloon interventional platform (DiLumen) is not used for removal of colonic polyp

Sponsors & Collaborators

  • Mercy Medical Center

    lead OTHER

Principal Investigators

  • Sergey V Kantsevoy, MD, PhD · Director of The Therapeutic Endoscopy Mercy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2020-03-15
Completion
2020-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03846609 on ClinicalTrials.gov