Evaluation of CG-100 Intraluminal Bypass Device

• Sponsor: Colospan Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05632744
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 9

Study Details

Study Description

Brief Summary

Evaluation of CG-100 Intraluminal Bypass device

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Device: CG-100 Intraluminal Bypass Device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of CG-100 Intraluminal Bypass Device
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Oct 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety of the CG-100 Intraluminal Bypass Device [10 days]

   Assessment of Serious Adverse Events

Secondary Outcome Measures

1. Safety of the CG-100 Intraluminal Bypass Device [4 weeks]

   Assessment of Serious Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Colospan Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colospan Ltd.
• ClinicalTrials.gov Identifier: NCT05632744
• Other Study ID Numbers: CLD-113
• First Posted: Dec 1, 2022
• Last Update Posted: Dec 7, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Dec 7, 2022