SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
SafeHeal Inc
Study ID
NCT07116668
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

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

Interventions

  • Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer — DEVICE
    Subjects in the Investigational cohort (SAFE-3CV) will undergo an LAR procedure followed by Colovac placement. Colovac retrieval will then occur at \~10 days post LAR procedure.

Study Details

Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.

Key Dates

Start date
Jan 8, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Colovac arm
    Subjects treated with the Colovac Device following low anterior resection of the colon will be enrolled in the investigational cohort.

Primary Outcome Measure

Performance: Clinically meaningful ostomy avoidance rate at Day 10 [ Time Frame: at 10 day visit ]

Locations (12)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Keck Medicine of USCLos AngelesCalifornia90033-
University of MiamiMiamiFlorida33146-
Tampa General HospitalTampaFlorida33606-
Boston Medical CenterBostonMassachusetts02118-
University of MassachusettsWorcesterMassachusetts01605-
Maimonides Medical CenterBrooklynNew York11219-
Lenox Hill HospitalNew YorkNew York10075-
Mount Sinai HospitalNew YorkNew York10029-
Novant HealthWinston-SalemNorth Carolina27103-
Geisinger Medical CenterDanvillePennsylvania17822-
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, CAKeck Medicine of USC· Los Angeles, CAUniversity of Miami· Miami, FLTampa General Hospital· Tampa, FLBoston Medical Center· Boston, MAUniversity of Massachusetts· Worcester, MA

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