SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

NCT07116668 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: SAFE-3CV
• Study Type: interventional
• Target: 108
• Locations: 4 countries
• Sites: 18

Brief Summary

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.

Conditions

Stoma - Ileostomy; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Performance: Clinically meaningful ostomy avoidance rate at Day 10

  The primary performance endpoint assessed for Colovac subjects at the Day 10 visit is a clinically meaningful ostomy avoidance rate that supports a favorable benefit risk when considering the primary safety endpoint.

  at 10 day visit

• Safety: Cumulative rate of Major Complications

  The primary safety endpoint is the cumulative rate of subjects with major complications through 9 months.

  9 months

Study Arms (1)

Colovac arm

EXPERIMENTAL

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

Device: Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer

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.

Colovac arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject meeting all of the following criteria will be considered for participation in the study:
• Adult patients (22 years of age or older)
• Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

You may not qualify if:

• Preoperative:
• Active colitis
• Known allergy to nickel or other components of the Colovac system
• Pregnant or nursing female subject
• Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol-described procedures or interfere with the interpretation of study results including, but not limited to:
• Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
• Immunodeficiency (CD4+ count \< 500 CU MM)
• Systemic and ongoing steroid therapy within the past 6 months
• Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
• Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
• Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, or carcinomatosis
• Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
• Severe malnutrition defined as 10% weight loss within 3 months prior to enrollment.
• The subject is currently participating in another investigational drug or device study that may confound the results of SAFE-3CV. Prior approval from SafeHeal Medical Monitor must be obtained prior to enrollment in SAFE-3CV.

Sponsors & Collaborators

• SafeHeal Inc: lead

Study Sites (18)

Keck Medicine of USC

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

UZA

Edegem, Antwerp, 2650, Belgium

Location

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Bordeaux Colorectal Institute

Bourdeaux, New Aquitaine, 33000, France

Location

Chu du Rouen

Rouen, Normandy, 76031, France

Location

Hopital Saint-Antoine

Paris, Île-de-France Region, 75012, France

Location

Humanitas Research Hospital

Rozzano, Lombardi, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

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

Model Details: The SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study is a prospective, non-randomized, sequential, IDE multicenter trial enrolling patients who are implanted with the investigational device, the Colovac Anastomosis Protection Device (next generation). These patients will be compared to a control group, the standard of care (diverting ostomy) and analyzed using a propensity subclassification approach with pre-specified covariates. The control data were collected as part of the SH-SOC23 study, a prospective, non-randomized, multicenter study sponsored by SafeHeal.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); FR (3); BE (2); IT (1)