SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
SafeHeal Inc
Study ID
NCT05010850
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colovac — DEVICE
    A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)
  • Stoma Creation — PROCEDURE
    Protective ileostomy

Study Details

A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

Key Dates

Start date
Jan 17, 2022
Status verified
Jun 2025
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Colovac
    Patients receive Colovac during colorectal surgery
  • Active Comparator: Standard of Care
    Patients receive the standard of care, a protective stoma, during colorectal surgery

Primary Outcome Measure

Avoidance of Ostomy [ Time Frame: 12 Months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Kaiser Permanente - Los AngelesLos AngelesCalifornia90027-
USC Keck HospitalLos AngelesCalifornia90033-
Tampa General HospitalTampaFlorida33606-
UMass Memorial Medical CenterWorcesterMassachusetts01605-
Dartmouth-HitchcockLebanonNew Hampshire03756-
Maimonides Medical CenterBrooklynNew York11219-
Lenox Hill HospitalNew YorkNew York10075-
Mount Sinai HospitalNew YorkNew York10029-
Lankenau Medical CenterWynnewoodPennsylvania19096-

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Cedars-Sinai Medical Center· Los Angeles, CAKaiser Permanente - Los Angeles· Los Angeles, CAUSC Keck Hospital· Los Angeles, CATampa General Hospital· Tampa, FLUMass Memorial Medical Center· Worcester, MADartmouth-Hitchcock· Lebanon, NH

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