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

• Conditions: Polyps of Colon
• Interventions: Device: DiLumen C2 Endolumenal Interventional Platform

• Registration Number: NCT04657601
• Lead Sponsor: Lumendi, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2020-10-22
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Start: 2021-01-15
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Men or women 18-85 years of age.
2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
3. Scheduled for endoscopic removal of suspected colorectal adenomatous polyps which are sessile or polypoid lesions.
4. Have, in the opinion of the Investigator(s) or co-investigator(s), no medical contraindication to endoscopic submucosal dissection (ESD).

Exclusion Criteria

1. Have a contraindication to colonoscopy, including but not limited to active colitis, diverticulitis, perforation, or stricture.
2. Have a history of open or laparoscopic colorectal surgery.
3. Have a history of Inflammatory Bowel Disease (IBD).
4. Have a suspected invasive malignancy on polyp assessment.
5. Any medical or surgical condition that would preclude the potential benefit ESD.
6. Any case where the device or instrument would be too large or too small to achieve a successful result.
7. Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area.
8. History of AIDS, HIV, or active hepatitis.
9. History of mental illness, including psychological or neurological conditions (addiction to substances such as alcohol. e.g.) that in the investigator's opinion would pre-empt their ability or willingness to participate in the study.
10. Has cardiopulmonary conditions that present prohibitive anesthesia risk.
11. Has uncorrectable coagulopathy or hemorrhagic diathesis.
12. Has an active infection or fever.
13. Has allergy to any component of the treatment procedure.
14. Patients who are pregnant.
15. Pediatric case (Age < 18 years)
16. Any case in which use of the DiLumen C2 device is not needed.
17. Any case not described in the indications.
18. Currently involved in another investigational product for similar purposes.
19. Prisoners.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	DiLumen C2 Endolumenal Interventional Platform	Patients undergo polypectomy facilitated by the study device.

Primary Outcome Measures

Name	Time	Method
The ability of the investigator to perform an endoscopic ESD safely and effectively	Through study completion, up to 7 days	Whether or not the polyp was removed and if there were any adverse events

Secondary Outcome Measures

Name	Time	Method
Details of the procedure	Through study completion, up to 7 days	Dissection speed
Legnth of Hospital Stay	Through study completion, up to 7 days	How long the patient was in the hospital following the polypectomy