Prospective Study of a New Endolumenal Device Used During Endoscopic Polypectomy in the Colon (DiLumenC2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Polyps of Colon
• Intervention / Treatment: Device: DiLumen C2 Endolumenal Interventional Platform

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 Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Patients undergo polypectomy facilitated by the study device.	Device: DiLumen C2 Endolumenal Interventional Platform; Dual balloon accessory to an endoscope and related instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Legnth of Hospital Stay	How long the patient was in the hospital following the polypectomy	Through study completion, up to 7 days

Collaborators and Investigators

• Sponsor: Lumendi, LLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Intestinal Polyps; Polyps; Pathologic Condition, Anatomical
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: USLUM 1802 or 2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No