NCT04657601

Prospective Study of a New Endolumenal Device Used During Endoscopic Polypectomy in the Colon

Prospective Evaluation Utilizing an Endolumenal Interventional Platform Device to Facilitate Endoscopic Polypectomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Lumendi, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Polyps of Colon

Interventions

Type	Name	Description
DEVICE	DiLumen C2 Endolumenal Interventional Platform	Dual balloon accessory to an endoscope and related instruments

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2020-12-08
• Last updated: 2020-12-08

Regulatory

• FDA-regulated device study