Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Patients undergo polypectomy facilitated by the study device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiLumen C2 Endolumenal Interventional Platform | Device | Dual balloon accessory to an endoscope and related instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ability of the investigator to perform an endoscopic ESD safely and effectively | Whether or not the polyp was removed and if there were any adverse events | Through study completion, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Details of the procedure | Procedure time | Through study completion, up to 7 days |
| Details of the procedure | Dissection speed | Through study completion, up to 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The subject population includes adults (ages 18-85 years) men and women scheduled to undergo a colorectal ESD. Subjects will be recruited from the investigator's standard patient population as seen in their routine clinical practice and will be screened for participation according to the protocol defined inclusion and exclusion criteria.
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Legnth of Hospital Stay | How long the patient was in the hospital following the polypectomy | Through study completion, up to 7 days |