NCT03846609

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

A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Mercy Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD procedures that are performed without use the DiLumen™ device. The study participants will be randomly assigned to study group and control group The treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments will include procedure timepoints, anesthesia use, polyp location and classification, over-all cost assessment, and general complications. The primary outcome will be analyzed using parametric statistics to compare the means of the study and control groups. P-values and confidence intervals will be reported. Descriptive and summary statistics will also be employed. Secondary outcomes will be summarized with descriptive statistics.

Conditions

• Colonic Polyp

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-03-15
• Completion: 2020-12-10
• First posted: 2019-02-19
• Last updated: 2020-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study