Back to resultsEvaluation of CG-100 Intraluminal Bypass Device
Primary Purpose
Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CG-100 Intraluminal Bypass Device
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria (pre-operative): Willing to comply with protocol-specified follow-up evaluations 22-75 (inclusive) years of age at screening Diagnosed with colorectal cancer Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CG-100 Intraluminal Bypass Device
Arm Description
Subjects will be treated with CG-100 Intraluminal Bypass Device
Outcomes
Primary Outcome Measures
Safety of the CG-100 Intraluminal Bypass Device
Assessment of Serious Adverse Events
Secondary Outcome Measures
Safety of the CG-100 Intraluminal Bypass Device
Assessment of Serious Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05632744
Brief Title
Evaluation of CG-100 Intraluminal Bypass Device
Official Title
Evaluation of CG-100 Intraluminal Bypass Device
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colospan Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of CG-100 Intraluminal Bypass device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CG-100 Intraluminal Bypass Device
Arm Type
Experimental
Arm Description
Subjects will be treated with CG-100 Intraluminal Bypass Device
Intervention Type
Device
Intervention Name(s)
CG-100 Intraluminal Bypass Device
Intervention Description
Subjects will be treated with the CG-100 Intraluminal Bypass Device
Primary Outcome Measure Information:
Title
Safety of the CG-100 Intraluminal Bypass Device
Description
Assessment of Serious Adverse Events
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Safety of the CG-100 Intraluminal Bypass Device
Description
Assessment of Serious Adverse Events
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (pre-operative):
Willing to comply with protocol-specified follow-up evaluations
22-75 (inclusive) years of age at screening
Diagnosed with colorectal cancer
Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Sharon
Phone
+972-50-2988415
Email
shelly@colospan.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of CG-100 Intraluminal Bypass Device
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