Evaluation of CG-100 Intraluminal Bypass Device

Evaluation of CG-100 Intraluminal Bypass device

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: CG-100 Intraluminal Bypass Device

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelly Sharon; Phone Number: +972-50-2988415; Email: shelly@colospan.com

Study Locations

• Israel
  • Reẖovot, Israel
    • Recruiting
    • Soroka Medical Center
    • Contact: Ilia Pinsk; Email: iliapi@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (pre-operative):

1. Willing to comply with protocol-specified follow-up evaluations
2. 22-75 (inclusive) years of age at screening
3. Diagnosed with colorectal cancer
4. Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CG-100 Intraluminal Bypass Device; Subjects will be treated with CG-100 Intraluminal Bypass Device	Device: CG-100 Intraluminal Bypass Device; Subjects will be treated with the CG-100 Intraluminal Bypass Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the CG-100 Intraluminal Bypass Device	Assessment of Serious Adverse Events	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the CG-100 Intraluminal Bypass Device	Assessment of Serious Adverse Events	4 weeks

Collaborators and Investigators

• Sponsor: Colospan Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CLD-113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No