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

NCT04657601 | Unknown FDA Device

• 1 other identifier: USLUM 1802 or 2020-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polyps of Colon

Keywords

Intestinal Polyps; Pathologic Condition, Anatomical; Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Details of the procedure

  Through study completion, up to 7 days

• Details of the procedure

  Through study completion, up to 7 days

• Legnth of Hospital Stay

  Through study completion, up to 7 days

Study Arms (1)

Treatment Group

Patients undergo polypectomy facilitated by the study device.

Device: DiLumen C2 Endolumenal Interventional Platform

Interventions

DiLumen C2 Endolumenal Interventional Platform DEVICE

Dual balloon accessory to an endoscope and related instruments

Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Have a contraindication to colonoscopy, including but not limited to active colitis, diverticulitis, perforation, or stricture.
• Have a history of open or laparoscopic colorectal surgery.
• Have a history of Inflammatory Bowel Disease (IBD).
• Have a suspected invasive malignancy on polyp assessment.
• Any medical or surgical condition that would preclude the potential benefit ESD.
• Any case where the device or instrument would be too large or too small to achieve a successful result.
• Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area.
• History of AIDS, HIV, or active hepatitis.
• 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.
• Has cardiopulmonary conditions that present prohibitive anesthesia risk.
• Has uncorrectable coagulopathy or hemorrhagic diathesis.
• Has an active infection or fever.
• Has allergy to any component of the treatment procedure.
• Patients who are pregnant.
• Pediatric case (Age \< 18 years)

Sponsors & Collaborators

• Lumendi, LLC: lead

MeSH Terms

Conditions

Colonic Polyps; Intestinal Polyps; Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 8, 2020
• Study Start: January 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 8, 2020

Record last verified: 2020-12