Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04657601 |
Other study ID # |
USLUM 1802 or 2020-01 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 15, 2021 |
Est. completion date |
March 2022 |
Study information
Verified date |
December 2020 |
Source |
Lumendi, LLC |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This prospective observational study will evaluate the performance of the DiLumen C2
Endolumenal Interventional Platform and its instruments. Up to 100 subjects will be enrolled
at up to 5 clinical sites. Patient data will be collected before the procedure, during the
procedure, and up until the patient is discharged from the hospital.
Description:
This study is a prospective, post-market evaluation of the performance of the DiLumen C2
Endolumenal Interventional Platform ("C2 device") used as an endoscopic dual balloon
accessory device used to ensure complete positioning, visualization, and diagnosis in
endoscopic treatments in the large intestine. The DiLumen Endolumenal Interventional Knife
("IK device") and the DiLumen Endolumenal Interventional Grasper ("IG device") are disposable
instruments used with the C2 device. These devices are cleared by the US Food and Drug
Administration (FDA) for commercial use in endolumenal therapies and will be used on-label in
this study. The overall goal of this study is to evaluate the clinical performance of the C2
device and its related instruments. Intra-procedure parameters (procedure timepoints,
anesthesia use, polyp location and description), final pathology/histology, and general
complications will also be evaluated. Investigators will also be asked to assess the ease of
use of the C2Interventional Platform.
To accomplish this goal, up to 100 subjects will be enrolled at up to 5 clinical sites and
treated using the C2 device and related instruments. Evaluations will be performed
pre-procedure, during the procedure, and at discharge. Assessments will include polyp
classification/pathology, procedure timepoints, final pathology/histology, adverse events,
and ease of use. As per the FDA cleared product labeling this study will be limited to
subjects undergoing an endoscopic procedure to remove polyps in the large intestine.