Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Part of paid clinical trials in Irvine, California.

Sponsor
Colospan Ltd.
Study ID
NCT04184973
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CG-100 intraluminal bypass device — DEVICE
    a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
  • Stoma — PROCEDURE
    Primary protective ileostomy

Study Details

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

Key Dates

First listed
Dec 4, 2019
Start date
Jun 23, 2020
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CG-100
    Patients receive CG-100 during rectal cancer surgery
  • Active Comparator: SOC
    Patients receive a protective stoma during rectal cancer surgery

Primary Outcome Measure

Change in Stoma creation rate [ Time Frame: 39 Weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92868-
Kaiser Permanente San Diego medical CenterSan DiegoCalifornia92123
Mike Fechter, LVN
[email protected]
(858) 266 - 6604
Daniel Klaristenfeld, MD (PRINCIPAL_INVESTIGATOR)
Marco Tomassi, MD (SUB_INVESTIGATOR)
Colorado University Anschutz Medical CampusAuroraColorado80045
Nargis Kalia
[email protected]
303-724-0333
Jon Vogel, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Anna Nefcy
[email protected]
3139169387
Craig Reickert, MD (PRINCIPAL_INVESTIGATOR)
Surya Nalamati, MD (SUB_INVESTIGATOR)
Edwin Itenberg, MD (SUB_INVESTIGATOR)
Lifespan & Brown Surgical AssociatesProvidenceRhode Island02906-
University of Utah HealthSalt Lake CityUtah84132-

Find similar trials in Irvine, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of California Irvine· Irvine, CAKaiser Permanente San Diego medical Center· San Diego, CAColorado University Anschutz Medical Campus· Aurora, COHenry Ford Health System· Detroit, MILifespan & Brown Surgical Associates· Providence, RIUniversity of Utah Health· Salt Lake City, UT

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