NCT05632744

Brief Summary

Evaluation of CG-100 Intraluminal Bypass device

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

November 8, 2022

Last Update Submit

February 12, 2024

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety of the CG-100 Intraluminal Bypass Device

    Assessment of Serious Adverse Events

    10 days

Secondary Outcomes (1)

  • Safety of the CG-100 Intraluminal Bypass Device

    4 weeks

Study Arms (1)

CG-100 Intraluminal Bypass Device

EXPERIMENTAL

Subjects will be treated with CG-100 Intraluminal Bypass Device

Device: CG-100 Intraluminal Bypass Device

Interventions

CG-100 Intraluminal Bypass DeviceDEVICE

Subjects will be treated with the CG-100 Intraluminal Bypass Device

CG-100 Intraluminal Bypass Device

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to comply with protocol-specified follow-up evaluations
  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Rehovot, Israel

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Shelly Sharon

CONTACT

+972-50-2988415shelly@colospan.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 1, 2022

Study Start

March 15, 2023

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)